TriangleNCT01609556 · OUTCOME
Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
What was measured
Laboratory parameters included serum chemistry (alanine aminotransferase \[ALT\]/serum glutamic pyruvic transaminase \[SGPT\], aspartate aminotransferase \[AST\]/serum glutamic oxaloacetic transaminase \[SGOT\], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio \[INR\], partial thromboplastin time \[PTT\]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade \<=2 to a post-baseline Grade 3/4 on-treatment, are reported.
Analysis population: Safety population included all participants who were enrolled and received at least 1 dose of study drug.
Groups in this outcome
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)
Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)
Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)
Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)
Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
| Group | Source count |
|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 2 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 1 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 1 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 1 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 9 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 18 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 7 |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 5 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 5 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 4 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 9 |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 7 |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 46 |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 24 |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 27 |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 40 |
Reported measurements
Glucose: Grade 0 to Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
Magnesium: Grade 2 to Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
PTT: Grade 2 to Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
Lymphocytes: Grade 0 to Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
Lymphocytes: Grade 2 to Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- title
- Glucose: Grade 0 to Grade 3
- categories
- measurements
- 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
- title
- Magnesium: Grade 2 to Grade 3
- categories
- measurements
- 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
- 1
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- PTT: Grade 2 to Grade 3
- categories
- measurements
- 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
- title
- Lymphocytes: Grade 0 to Grade 3
- categories
- measurements
- 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
- title
- Lymphocytes: Grade 2 to Grade 3
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 9
- group Id
- OG005
- value
- 18
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 5
- group Id
- OG009
- value
- 4
- group Id
- OG010
- value
- 9
- group Id
- OG011
- value
- 7
- units
- Participants
- description
- Laboratory parameters included serum chemistry (alanine aminotransferase \[ALT\]/serum glutamic pyruvic transaminase \[SGPT\], aspartate aminotransferase \[AST\]/serum glutamic oxaloacetic transaminase \[SGOT\], albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, magnesium, phosphorous, potassium, sodium), hematology (hemoglobin, lymphocytes, neutrophils, platelets, white blood cells) and coagulation (international normalized ratio \[INR\], partial thromboplastin time \[PTT\]). Clinically significant laboratory values were defined as per NCI CTCAE v.03 Grade 3 or higher. A grading (severity) scale was provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Only participants who shifted from a baseline value of Grade \<=2 to a post-baseline Grade 3/4 on-treatment, are reported.
- groups
- description
- Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG000
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG001
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG002
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG003
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG004
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG005
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG006
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG007
- title
- Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)
- description
- Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG008
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)
- description
- Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG009
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)
- description
- Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG010
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)
- description
- Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.
- id
- OG011
- title
- Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population included all participants who were enrolled and received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)
- title
- Number of Participants With Shift From Baseline Grade <=2 in Clinical Laboratory Parameters to Grade 3 or Grade 4 on Study
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice