Participant flow

Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2024-10-26

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

groups

1. description

   Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.

   id

   FG000

   title

   Placebo + Carboplatin + Paclitaxel -> Placebo

2. description

   Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.

   id

   FG001

   title

   Veliparib + Carboplatin + Paclitaxel -> Placebo

3. description

   Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.

   id

   FG002

   title

   Veliparib + Carboplatin + Paclitaxel -> Veliparib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         224

      2. group Id

         FG001

         num Subjects

         227

      3. group Id

         FG002

         num Subjects

         199

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         22

      3. group Id

         FG002

         num Subjects

         31

      type

      Withdrew consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         13

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         117

      2. group Id

         FG001

         num Subjects

         110

      3. group Id

         FG002

         num Subjects

         122

      type

      Sponsor discontinued study

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         14

      type

      Other, not specified

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         3

      type

      Missing due to site non-compliance

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         375

      2. group Id

         FG001

         num Subjects

         383

      3. group Id

         FG002

         num Subjects

         382

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         375

      2. group Id

         FG001

         num Subjects

         383

      3. group Id

         FG002

         num Subjects

         382

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified according to the timing of surgery and residual disease after primary surgery or interval surgery, the paclitaxel schedule, stage of disease, geographic region, and germline breast cancer susceptibility gene (BRCA) mutation status.

recruitment Details

This trial was conducted at 188 sites in 10 countries (Australia, Brazil, Denmark, Israel, Japan, Poland, Republic of Korea, Spain, United Kingdom, and United States).

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Preserved source evidence · Not medical advice