TriangleNCT01064648 · OUTCOME
Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- mg
- Interval / dispersion
- Not reported
- Time frame
- Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment.
What was measured
MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to one of the 3 study drugs). The following events occurring in the first cycle of treatment are considered dose limiting. 1. Febrile neutropenia 2. Grade 4 neutrophil count decrease for more than 7 days' duration 3. Grade 4 platelet count decrease 4. Grade 3 or 4 non-hematologic toxicity (excluding alopecia)
Groups in this outcome
All Phase I Participants
All participants from Phase I who are eligible for DLT. Patients will be considered evaluable for DLT if they received at least 14 doses of cediranib at the assigned dose during Cycle 1 and at least one dose each of pemetrexed and cisplatin, or if they developed a DLT. If a patient does not develop a DLT but does not complete at least 14 doses of cediranib and one dose each of pemetrexed and cisplatin during Cycle 1 due to any reason, the patient will be considered not evaluable for DLT and will be replaced.
| Group | Source count |
|---|---|
| All Phase I Participants | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Phase I Participants | 20 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- MTD was determined by testing dose-de-escalation to 20mg PO daily on dose de-escalation cohort 1 to 2 with 3 to 6 patients each. MTD reflects the highest dose of drug that did not cause a Dose-Limiting Toxicity (DLT) in \> 33% of participants. Toxicities will be graded according to the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events. Dose-limiting toxicities (DLT) apply only during Cycle 1 and must be drug-related (i.e. possibly, probably or definitely related to one of the 3 study drugs). The following events occurring in the first cycle of treatment are considered dose limiting. 1. Febrile neutropenia 2. Grade 4 neutrophil count decrease for more than 7 days' duration 3. Grade 4 platelet count decrease 4. Grade 3 or 4 non-hematologic toxicity (excluding alopecia)
- groups
- description
- All participants from Phase I who are eligible for DLT. Patients will be considered evaluable for DLT if they received at least 14 doses of cediranib at the assigned dose during Cycle 1 and at least one dose each of pemetrexed and cisplatin, or if they developed a DLT. If a patient does not develop a DLT but does not complete at least 14 doses of cediranib and one dose each of pemetrexed and cisplatin during Cycle 1 due to any reason, the patient will be considered not evaluable for DLT and will be replaced.
- id
- OG000
- title
- All Phase I Participants
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- Weekly during first cycle (1cycle = 21 days). Then will be reported every cycle while patient is on treatment.
- title
- Maximum Tolerated Dose of Cediranib in Combination With Cisplatin and Pemetrexed (Phase I)
- type
- PRIMARY
- unit Of Measure
- mg
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice