TriangleNCT03598998 · OUTCOME
Number of Participants Who Had Dose Limiting Toxicities
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 the start of Cycle 1 through the start of Cycle 3 (approximately 42 days)
What was measured
Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Analysis population: Two patients in dose level 1 and one patient in dose level 2 were not evaluable for DLT.
Groups in this outcome
Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2 | 5 |
| Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- units
- Participants
- description
- Dose limiting toxicities (DLT) were defined as one of the AEs in Protocol Section 5.5 that at least possibly related to study treatment. The DLT observation period was 2 cycles of therapy, from the start of Cycle 1 through the start of Cycle 3. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
- groups
- description
- Patients receive pralatrexate 20mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Phase I - Dose Level 1: Pembrolizumab 200mg + Pralatrexate 20mg/m2
- description
- Patients receive pralatrexate 30mg/m2 IV over 3-5 minutes on days 1 and 8 and pembrolizumab 200mg IV over 30 minutes on day 1. Courses repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Phase I - Dose Level 2: Pembrolizumab 200mg + Pralatrexate 30mg/m2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Two patients in dose level 1 and one patient in dose level 2 were not evaluable for DLT.
- reporting Status
- POSTED
- time Frame
- From the start of Cycle 1 through the start of Cycle 3 (approximately 42 days)
- title
- Number of Participants Who Had Dose Limiting Toxicities
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice