TriangleNCT00481871 · OUTCOME
Duration of Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- Full Range
- Time frame
- Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study
What was measured
Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1)
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 | 8 |
| Phase 2 - Group B | 5 |
| Phase 2 - Group C | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 | 174 | Not reported | 35 | 288 | Not reported |
| Phase 2 - Group B | 210 | Not reported | 57 | 210 | Not reported |
| Phase 2 - Group C | 170 | Not reported | 59 | 178 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35
- upper Limit
- 288
- value
- 174
- group Id
- OG001
- lower Limit
- 57
- upper Limit
- 210
- value
- 210
- group Id
- OG002
- lower Limit
- 59
- upper Limit
- 178
- value
- 170
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 7
- units
- Participants
- description
- Duration of response was defined as the number of days between the date of first tumor response assessment of objective response to the time of the first tumor response assessment of progressive disease (PD) or death due to any cause (date of first PD assessment or death - date of first objective response assessment + 1)
- dispersion Type
- Full Range
- 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
- MEDIAN
- reporting Status
- POSTED
- time Frame
- Response assessments were performed no less than every 3 cycles in the Phase 1 part of the study and every 8 weeks (± 1 week) in the Phase 2a part of the study
- title
- Duration of Response
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice