Participant flow

RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT) · Source last updated 2025-03-17

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

groups

1. description

   4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy

   id

   FG000

   title

   RRx-001 + Platinum Doublet (A01-09)

2. description

   RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).

   id

   FG001

   title

   RRx-001 + Platinum + RRx-001 (A10)

3. description

   Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity

   id

   FG002

   title

   Investigator's Choice (A10)

4. description

   Subjects were screened and did not get Randomized

   id

   FG003

   title

   Screening (Pre-Randomization) (A10)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         8

      type

      Screen Failure

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         21

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         13

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         8

      type

      NOT COMPLETED

   title

   Screening

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Baseline Drop Out

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         11

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         75

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Randomized and Received Treatment

pre Assignment Details

139 participants provided consent. 118 patients consented under Amendment 01-09. 21 patients were consented on Amendment 10 with 13 randomized in the study. A total of 92 patients under Amendment 01-09 and 13 patients under Amendment 10, combined 107 patients.

recruitment Details

Participants were recruited based on physician referral at 13 academic medical centers between June 2015 and October 2020. The first participant first visit was June 12, 2015 and the last patient last visit was October 8, 2020.

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Preserved source evidence · Not medical advice