TriangleNCT00481871 · OUTCOME
Objective Responses Assessed by International Workshop Criteria (IWC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I
What was measured
Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
Analysis population: All patients who completed at least 1 cycle of treatment were included in the efficacy analysis
Groups in this outcome
Phase 1
Includes the Phase 1 dose-finding groups A, B, and C
Phase 2 - Group B
Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
Phase 2 - Group C
Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
| Group | Source count |
|---|---|
| Phase 1 | 34 |
| Phase 2 - Group B | 38 |
| Phase 2 - Group C | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 | 8 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 - Group B | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 - Group C | 7 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 7
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 34
- units
- Participants
- description
- Number of participants who achieved an objective response. Objective response was defined as a tumor response assessment of either complete response (CR) or partial response (PR) and was determined only for patients with measurable disease at baseline. A tumor response assessment reported by IWC without PET was used for any analyses in cases where an IWC+PET evaluation was not done.
- groups
- description
- Includes the Phase 1 dose-finding groups A, B, and C
- id
- OG000
- title
- Phase 1
- description
- Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
- id
- OG001
- title
- Phase 2 - Group B
- description
- Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
- id
- OG002
- title
- Phase 2 - Group C
- param Type
- NUMBER
- population Description
- All patients who completed at least 1 cycle of treatment were included in the efficacy analysis
- reporting Status
- POSTED
- time Frame
- Assessed every 8 weeks (+/- 1 week) for Phase II and no less than every 3 cycles for Phase I
- title
- Objective Responses Assessed by International Workshop Criteria (IWC)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice