TriangleNCT02631876 · OUTCOME
Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses
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
- From first dose of study drug until CA-125 response (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
What was measured
CA-125 Response rate wasdefined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100.
Analysis population: CA-125-Evaluable population included all randomized population whose pretreatment sample 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 received MIRV mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
Investigator's Choice (IC) Chemotherapy
Participants received a dose of 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. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
| Group | Source count |
|---|---|
| Mirvetuximab Soravtansine | 203 |
| Investigator's Choice (IC) Chemotherapy | 82 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Mirvetuximab Soravtansine | 51 | Not reported | 44.1 | 58.3 | Not reported |
| Investigator's Choice (IC) Chemotherapy | 27 | Not reported | 17.6 | 37.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 44.1
- upper Limit
- 58.3
- value
- 51
- group Id
- OG001
- lower Limit
- 17.6
- upper Limit
- 37.8
- value
- 27
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 82
- units
- Participants
- description
- CA-125 Response rate wasdefined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received MIRV mirvetuximab soravtansine at 6 mg/kg AIBW administered IV on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)
- id
- OG000
- title
- Mirvetuximab Soravtansine
- description
- Participants received a dose of 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. Participants continued to receive study drug until they experienced PD per RECIST version 1.1 (as assessed by BIRC), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 62.9 weeks)
- id
- OG001
- title
- Investigator's Choice (IC) Chemotherapy
- param Type
- NUMBER
- population Description
- CA-125-Evaluable population included all randomized population whose pretreatment sample 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
- From first dose of study drug until CA-125 response (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)
- title
- Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice