TriangleNCT02004275 · OUTCOME
Incidence and Type of Dose Limiting Toxicities (DLTs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Phase I)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants with DLT
- Interval / dispersion
- Not reported
- Time frame
- 44.5 months
What was measured
These events are reported in the adverse events section of this report.
Analysis population: All enrolled phase 1 patients that were eligible and treated per protocol were evaluated for dose limiting toxicities. This excludes two dose level 2 patients, one dose level 3 patient and 5 dose level 4 patients.
Groups in this outcome
Phase 1 Dose Level 1
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.
Phase 1 Dose Level 2
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.
Phase 1 Dose Level 3
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 4mg POM-DEX and 3mg IXA.
Phase 1 Dose Level 4
A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 4mg POM-DEX and 4mg IXA.
| Group | Source count |
|---|---|
| Phase 1 Dose Level 1 | 3 |
| Phase 1 Dose Level 2 | 3 |
| Phase 1 Dose Level 3 | 6 |
| Phase 1 Dose Level 4 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Level 2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Dose Level 4 | 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
- 1
- group Id
- OG003
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- These events are reported in the adverse events section of this report.
- groups
- description
- A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 2mg POM-DEX and 3mg IXA.
- id
- OG000
- title
- Phase 1 Dose Level 1
- description
- A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 2 was 3mg POM-DEX and 3mg IXA.
- id
- OG001
- title
- Phase 1 Dose Level 2
- description
- A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 4mg POM-DEX and 3mg IXA.
- id
- OG002
- title
- Phase 1 Dose Level 3
- description
- A 3 + 3 phase I dose escalation design was used to examine the safety profile and establish the MTD of IXA when given in combination with POM-DEX. Protocol therapy was administered over a 28-day cycle. IXA was given at a dose of 2.3 up to 4 mg by mouth on days 1, 8, and 15; POM at 2 up to 4 mg daily by mouth on days 1-21; and DEX 20 mg (age \> 75 years) or 40 mg (age ≤ 75) by mouth on days 1, 8, 15, and 22 (Table 1). A new cycle of treatment was not to begin until the ANC was ≥ 1.0 × 109/L, platelets ≥ 50 × 109/L, and all other adverse events (AEs) had improved to grade 1 or baseline. Treatment continued until PD, the emergence of unacceptable toxicity, or patient request to discontinue protocol treatment. Dose Level 1 was 4mg POM-DEX and 4mg IXA.
- id
- OG003
- title
- Phase 1 Dose Level 4
- param Type
- NUMBER
- population Description
- All enrolled phase 1 patients that were eligible and treated per protocol were evaluated for dose limiting toxicities. This excludes two dose level 2 patients, one dose level 3 patient and 5 dose level 4 patients.
- reporting Status
- POSTED
- time Frame
- 44.5 months
- title
- Incidence and Type of Dose Limiting Toxicities (DLTs) Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (Phase I)
- type
- SECONDARY
- unit Of Measure
- participants with DLT
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Preserved source evidence · Not medical advice