Participant flow

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer · Source last updated 2020-10-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received mirvetuximab soravtansine at 6 milligrams/kilogram (mg/kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of a 3 week cycle. Participants continued to receive study drug until they experienced progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee \[BIRC\]), experienced unacceptable toxicity, or withdrew consent, whichever came first, or until the sponsor terminated the study. (Maximum exposure: 86.9 weeks)

   id

   FG000

   title

   Mirvetuximab Soravtansine

2. description

   Participants received a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (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

   FG001

   title

   Investigator's Choice (IC) Chemotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         96

      2. group Id

         FG001

         num Subjects

         50

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Investigator's discretion

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         9

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      type

      Other than specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         248

      2. group Id

         FG001

         num Subjects

         118

      comment

      ITT population: all participants randomized in the study.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         243

      2. group Id

         FG001

         num Subjects

         109

      comment

      Enrolled participants who received at least 1 dose of mirvetuximab soravtansine or IC chemotherapy.

      type

      Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         129

      2. group Id

         FG001

         num Subjects

         55

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         119

      2. group Id

         FG001

         num Subjects

         63

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

A total of 366 participants were randomized in 2:1 to receive either mirvetuximab soravtansine or the investigator's choice (IC) chemotherapy.

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Preserved source evidence · Not medical advice