TriangleNCT03269136 · OUTCOME
Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Microgram*day per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
What was measured
Area under the concentration curve from time 0 to end of dosing interval (AUCtau) was measured in this outcome measure. Total is free and bound drug in the body.
Analysis population: PK parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.
Groups in this outcome
Part 1: PF-06863135 0.1 mcg/kg IV
Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 0.3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 3 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 10 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 30 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 50 mcg/kg IV
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 80 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 130 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 215 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 360 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 600 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1: PF-06863135 1000 mcg/kg SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1000 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q1W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every week (Q1W) on Day 1, 8, 15 and 22 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1.1: PF-06863135 Priming Cohort Q2W SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 600 mcg/kg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 1000 mcg/kg as a SC injection every 2 weeks (Q2W) on Day 1 and 15 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1C: PF-06863135 + Lenalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with lenalidomide at dose of 15 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
Part 1D: PF-06863135 + Pomalidomide SC
Participants with relapsed/refractory advanced MM received PF-06863135 at a priming dose of 32 mcg as a SC injection, on Day 1 of Cycle 0. Participants received maintenance dose of 44 mcg as a SC injection Q1W on Day 1, 8, 15 and 22 along with pomalidomide at dose of 4 mg, orally, daily on Days 1-21 of each 28-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 3 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 6 |
| Part 1: PF-06863135 80 mcg/kg SC | 6 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 4 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 12 |
| Part 1C: PF-06863135 + Lenalidomide SC | 4 |
| Part 1D: PF-06863135 + Pomalidomide SC | 9 |
Reported measurements
Total PF-06863135: Cycle 0 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 0 |
| Part 1: PF-06863135 1 mcg/kg IV | 0 |
| Part 1: PF-06863135 3 mcg/kg IV | 0 |
| Part 1: PF-06863135 10 mcg/kg IV | 0 |
| Part 1: PF-06863135 30 mcg/kg IV | 0 |
| Part 1: PF-06863135 50 mcg/kg IV | 0 |
| Part 1: PF-06863135 80 mcg/kg SC | 0 |
| Part 1: PF-06863135 130 mcg/kg SC | 0 |
| Part 1: PF-06863135 215 mcg/kg SC | 0 |
| Part 1: PF-06863135 360 mcg/kg SC | 0 |
| Part 1: PF-06863135 600 mcg/kg SC | 0 |
| Part 1: PF-06863135 1000 mcg/kg SC | 0 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 10 |
| Part 1C: PF-06863135 + Lenalidomide SC | 3 |
| Part 1D: PF-06863135 + Pomalidomide SC | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 16.82 | 20 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 16.93 | 46 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 9.643 | 148 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 10.91 | 37 | Not reported | Not reported | Not reported |
Total PF-06863135: Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 1 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 5 |
| Part 1: PF-06863135 80 mcg/kg SC | 3 |
| Part 1: PF-06863135 130 mcg/kg SC | 3 |
| Part 1: PF-06863135 215 mcg/kg SC | 2 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 4 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 5 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 8 |
| Part 1C: PF-06863135 + Lenalidomide SC | 3 |
| Part 1D: PF-06863135 + Pomalidomide SC | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.00829. |
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00933 and 0.0136. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0483 and 0.0484. |
| Part 1: PF-06863135 3 mcg/kg IV | 0.1654 | 74 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.763 and 0.877. |
| Part 1: PF-06863135 30 mcg/kg IV | 2.190 | 11 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 3.322 | 40 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 1.182 | 58 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 4.426 | 17 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.35 and 6.09. |
| Part 1: PF-06863135 360 mcg/kg SC | 12.58 | 26 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 17.92 | 29 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 25.53 | 36 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 58.93 | 14 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 93.96 | 53 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 54.78 | 16 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 31.92 | 45 | Not reported | Not reported | Not reported |
Total PF-06863135: Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 1 |
| Part 1: PF-06863135 1 mcg/kg IV | 1 |
| Part 1: PF-06863135 3 mcg/kg IV | 0 |
| Part 1: PF-06863135 10 mcg/kg IV | 0 |
| Part 1: PF-06863135 30 mcg/kg IV | 2 |
| Part 1: PF-06863135 50 mcg/kg IV | 2 |
| Part 1: PF-06863135 80 mcg/kg SC | 2 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 0 |
| Part 1: PF-06863135 360 mcg/kg SC | 2 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 4 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 3 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 4 |
| Part 1C: PF-06863135 + Lenalidomide SC | 0 |
| Part 1D: PF-06863135 + Pomalidomide SC | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0276. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0790. |
| Part 1: PF-06863135 30 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.88 and 4.36. |
| Part 1: PF-06863135 50 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 7.91 and 8.10. |
| Part 1: PF-06863135 80 mcg/kg SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.77 and 10.1. |
| Part 1: PF-06863135 130 mcg/kg SC | 13.47 | 39 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 32.2 and 42.2. |
| Part 1: PF-06863135 600 mcg/kg SC | 76.83 | 30 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 88.92 | 31 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 173.4 | 21 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 148.1 | 65 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 71.7 and 77.8. |
Free PF-06863135: Cycle 0 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 0 |
| Part 1: PF-06863135 1 mcg/kg IV | 0 |
| Part 1: PF-06863135 3 mcg/kg IV | 0 |
| Part 1: PF-06863135 10 mcg/kg IV | 0 |
| Part 1: PF-06863135 30 mcg/kg IV | 0 |
| Part 1: PF-06863135 50 mcg/kg IV | 0 |
| Part 1: PF-06863135 80 mcg/kg SC | 0 |
| Part 1: PF-06863135 130 mcg/kg SC | 0 |
| Part 1: PF-06863135 215 mcg/kg SC | 0 |
| Part 1: PF-06863135 360 mcg/kg SC | 0 |
| Part 1: PF-06863135 600 mcg/kg SC | 0 |
| Part 1: PF-06863135 1000 mcg/kg SC | 0 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 6 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 10 |
| Part 1C: PF-06863135 + Lenalidomide SC | 3 |
| Part 1D: PF-06863135 + Pomalidomide SC | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 4.111 | 49 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 5.054 | 73 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 2.447 | 92 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 3.487 | 50 | Not reported | Not reported | Not reported |
Free PF-06863135: Cycle 1 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 2 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 2 |
| Part 1: PF-06863135 3 mcg/kg IV | 3 |
| Part 1: PF-06863135 10 mcg/kg IV | 2 |
| Part 1: PF-06863135 30 mcg/kg IV | 5 |
| Part 1: PF-06863135 50 mcg/kg IV | 5 |
| Part 1: PF-06863135 80 mcg/kg SC | 3 |
| Part 1: PF-06863135 130 mcg/kg SC | 3 |
| Part 1: PF-06863135 215 mcg/kg SC | 2 |
| Part 1: PF-06863135 360 mcg/kg SC | 4 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 4 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 5 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 8 |
| Part 1C: PF-06863135 + Lenalidomide SC | 3 |
| Part 1D: PF-06863135 + Pomalidomide SC | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 3 mcg/kg IV | 0.0009462 | 1.95 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 10 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.261 and 0.618. |
| Part 1: PF-06863135 30 mcg/kg IV | 0.7801 | 24 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | 1.206 | 62 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 80 mcg/kg SC | 0.3344 | 72 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 130 mcg/kg SC | 1.478 | 23 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 215 mcg/kg SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 2.67 and 3.29. |
| Part 1: PF-06863135 360 mcg/kg SC | 4.362 | 103 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 600 mcg/kg SC | 4.909 | 42 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 6.564 | 33 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 11.92 | 109 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 34.13 | 60 | Not reported | Not reported | Not reported |
| Part 1C: PF-06863135 + Lenalidomide SC | 8.896 | 12 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | 11.40 | 91 | Not reported | Not reported | Not reported |
Free PF-06863135: Cycle 2 Day 1
| Group | Source count |
|---|---|
| Part 1: PF-06863135 0.1 mcg/kg IV | 0 |
| Part 1: PF-06863135 0.3 mcg/kg IV | 2 |
| Part 1: PF-06863135 1 mcg/kg IV | 1 |
| Part 1: PF-06863135 3 mcg/kg IV | 2 |
| Part 1: PF-06863135 10 mcg/kg IV | 1 |
| Part 1: PF-06863135 30 mcg/kg IV | 3 |
| Part 1: PF-06863135 50 mcg/kg IV | 2 |
| Part 1: PF-06863135 80 mcg/kg SC | 2 |
| Part 1: PF-06863135 130 mcg/kg SC | 4 |
| Part 1: PF-06863135 215 mcg/kg SC | 0 |
| Part 1: PF-06863135 360 mcg/kg SC | 2 |
| Part 1: PF-06863135 600 mcg/kg SC | 6 |
| Part 1: PF-06863135 1000 mcg/kg SC | 4 |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 3 |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 4 |
| Part 1C: PF-06863135 + Lenalidomide SC | 0 |
| Part 1D: PF-06863135 + Pomalidomide SC | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06863135 0.3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 1 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000. |
| Part 1: PF-06863135 3 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000. |
| Part 1: PF-06863135 10 mcg/kg IV | NA | Not reported | Not reported | Not reported | Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000. |
| Part 1: PF-06863135 30 mcg/kg IV | 0.05280 | 2.59 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 50 mcg/kg IV | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 1.51 and 1.57. |
| Part 1: PF-06863135 80 mcg/kg SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 2.15. |
| Part 1: PF-06863135 130 mcg/kg SC | 2.572 | 49 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 360 mcg/kg SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.43 and 6.57. |
| Part 1: PF-06863135 600 mcg/kg SC | 45.14 | 113 | Not reported | Not reported | Not reported |
| Part 1: PF-06863135 1000 mcg/kg SC | 34.18 | 155 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q1W SC | 45.63 | 128 | Not reported | Not reported | Not reported |
| Part 1.1: PF-06863135 Priming Cohort Q2W SC | 66.20 | 63 | Not reported | Not reported | Not reported |
| Part 1D: PF-06863135 + Pomalidomide SC | NA | NA | Not reported | Not reported | Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 64.2 and 71.2. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG013
- spread
- 20
- value
- 16.82
- group Id
- OG014
- spread
- 46
- value
- 16.93
- group Id
- OG015
- spread
- 148
- value
- 9.643
- group Id
- OG016
- spread
- 37
- value
- 10.91
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Total PF-06863135: Cycle 0 Day 1
- categories
- measurements
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.00829.
- group Id
- OG000
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.00933 and 0.0136.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.0483 and 0.0484.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 74
- value
- 0.1654
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.763 and 0.877.
- group Id
- OG004
- spread
- NA
- value
- NA
- group Id
- OG005
- spread
- 11
- value
- 2.190
- group Id
- OG006
- spread
- 40
- value
- 3.322
- group Id
- OG007
- spread
- 58
- value
- 1.182
- group Id
- OG008
- spread
- 17
- value
- 4.426
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.35 and 6.09.
- group Id
- OG009
- spread
- NA
- value
- NA
- group Id
- OG010
- spread
- 26
- value
- 12.58
- group Id
- OG011
- spread
- 29
- value
- 17.92
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Total PF-06863135: Cycle 1 Day 1
- categories
- measurements
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0276.
- group Id
- OG001
- value
- NA
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.0790.
- group Id
- OG002
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.88 and 4.36.
- group Id
- OG005
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 7.91 and 8.10.
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 3.77 and 10.1.
- group Id
- OG007
- spread
- NA
- value
- NA
- group Id
- OG008
- spread
- 39
- value
- 13.47
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 32.2 and 42.2.
- group Id
- OG010
- spread
- NA
- value
- NA
- group Id
- OG011
- spread
- 30
- value
- 76.83
- group Id
- OG012
- spread
- 31
- value
- 88.92
- group Id
- OG013
- spread
- 21
- value
- 173.4
- group Id
- OG014
- spread
- 65
- value
- 148.1
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 71.7 and 77.8.
- group Id
- OG016
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Total PF-06863135: Cycle 2 Day 1
- categories
- measurements
- group Id
- OG013
- spread
- 49
- value
- 4.111
- group Id
- OG014
- spread
- 73
- value
- 5.054
- group Id
- OG015
- spread
- 92
- value
- 2.447
- group Id
- OG016
- spread
- 50
- value
- 3.487
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- units
- Participants
- title
- Free PF-06863135: Cycle 0 Day 1
- categories
- measurements
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG002
- spread
- NA
- value
- NA
- group Id
- OG003
- spread
- 1.95
- value
- 0.0009462
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.261 and 0.618.
- group Id
- OG004
- spread
- NA
- value
- NA
- group Id
- OG005
- spread
- 24
- value
- 0.7801
- group Id
- OG006
- spread
- 62
- value
- 1.206
- group Id
- OG007
- spread
- 72
- value
- 0.3344
- group Id
- OG008
- spread
- 23
- value
- 1.478
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 2.67 and 3.29.
- group Id
- OG009
- spread
- NA
- value
- NA
- group Id
- OG010
- spread
- 103
- value
- 4.362
- group Id
- OG011
- spread
- 42
- value
- 4.909
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 2
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Free PF-06863135: Cycle 1 Day 1
- categories
- measurements
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.
- group Id
- OG002
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 0.000.
- group Id
- OG003
- spread
- NA
- value
- NA
- comment
- Since only 1 participant evaluable, summary statistics could not be calculated. Individual participant data was 0.000.
- group Id
- OG004
- value
- NA
- group Id
- OG005
- spread
- 2.59
- value
- 0.05280
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 1.51 and 1.57.
- group Id
- OG006
- spread
- NA
- value
- NA
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 0.000 and 2.15.
- group Id
- OG007
- spread
- NA
- value
- NA
- group Id
- OG008
- spread
- 49
- value
- 2.572
- comment
- Since there were only 2 participants evaluable, summary statistics was not calculated. Individual participants data was 4.43 and 6.57.
- group Id
- OG010
- spread
- NA
- value
- NA
- group Id
- OG011
- spread
- 113
- value
- 45.14
- group Id
- OG012
- spread
- 155
- value
- 34.18
- group Id
- OG013
- spread
- 128
- value
- 45.63
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 2
- group Id
- OG011
- value
- 6
- units
- Participants
- title
- Free PF-06863135: Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 4
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 4
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- Area under the concentration curve from time 0 to end of dosing interval (AUCtau) was measured in this outcome measure. Total is free and bound drug in the body.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with relapsed/refractory advanced multiple myeloma (MM) received PF-06863135 at a dose of 0.1 microgram/kilogram (mcg/kg) as an intravenous (IV) infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG000
- title
- Part 1: PF-06863135 0.1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 0.3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG001
- title
- Part 1: PF-06863135 0.3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 1 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG002
- title
- Part 1: PF-06863135 1 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 3 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG003
- title
- Part 1: PF-06863135 3 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 10 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG004
- title
- Part 1: PF-06863135 10 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 30 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG005
- title
- Part 1: PF-06863135 30 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 50 mcg/kg as an IV infusion for 2 hours on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG006
- title
- Part 1: PF-06863135 50 mcg/kg IV
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 80 mcg/kg as a subcutaneous (SC) injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG007
- title
- Part 1: PF-06863135 80 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 130 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG008
- title
- Part 1: PF-06863135 130 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 215 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG009
- title
- Part 1: PF-06863135 215 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 360 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG010
- title
- Part 1: PF-06863135 360 mcg/kg SC
- description
- Participants with relapsed/refractory advanced MM received PF-06863135 at a dose of 600 mcg/kg as a SC injection on Day 1, 8 and 15 of each 21-day cycle. Participants received treatment until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination, whichever occurred first.
- id
- OG011
- title
- Part 1: PF-06863135 600 mcg/kg SC
- param Type
- GEOMETRIC_MEAN
- population Description
- PK parameter analysis set was defined as all enrolled participants treated who had sufficient information to estimate at least 1 of the PF- 06863135 PK parameters of interest. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here, "Number Analyzed" signifies number of participants evaluable at specified rows.
- reporting Status
- POSTED
- time Frame
- 0 hours (h) on Day 1 of Cycle (C) 0; 0, 2 and 4h on Day 1 of C1 and C2
- title
- Part 1: Area Under the Concentration-Time Profile From Time 0 to End of Dosing Interval (AUCtau)
- type
- SECONDARY
- unit Of Measure
- Microgram*day per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice