TriangleNCT04209855 · OUTCOME
Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline up to approximately 36 months
What was measured
The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
Analysis population: The CA-125-Evaluable Population included all randomized participants who received at least 1 dose of MIRV or IC Chemo, whose pretreatment CA-125 was ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to randomization, and who had at least 1 post-baseline CA-125 evaluation.
Groups in this outcome
Mirvetuximab Soravtansine
Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
Investigator's Choice (IC) Chemotherapy
Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
| Group | Source count |
|---|---|
| Mirvetuximab Soravtansine | 181 |
| Investigator's Choice (IC) Chemotherapy | 156 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mirvetuximab Soravtansine | 58.0 | Not reported | 50.5 | 65.3 | Not reported |
| Investigator's Choice (IC) Chemotherapy | 30.1 | Not reported | 23.1 | 38.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.5
- upper Limit
- 65.3
- value
- 58.0
- group Id
- OG001
- lower Limit
- 23.1
- upper Limit
- 38.0
- value
- 30.1
- denoms
- counts
- group Id
- OG000
- value
- 181
- group Id
- OG001
- value
- 156
- units
- Participants
- description
- The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants randomized to single-agent MIRV at 6 mg/kg AIBW administered IV on Day 1 of Q3W.
- id
- OG000
- title
- Mirvetuximab Soravtansine
- description
- Participants randomized to IC chemotherapeutic agent calculated using BSA. Paclitaxel administered at 80 mg/m\^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could have been administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could have been administered as a 1-hour infusion.
- id
- OG001
- title
- Investigator's Choice (IC) Chemotherapy
- param Type
- NUMBER
- population Description
- The CA-125-Evaluable Population included all randomized participants who received at least 1 dose of MIRV or IC Chemo, whose pretreatment CA-125 was ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to randomization, and who had at least 1 post-baseline CA-125 evaluation.
- reporting Status
- POSTED
- time Frame
- Baseline up to approximately 36 months
- title
- Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice