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NCT02489903 · OUTCOME

Overall Response Rate (ORR)

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Assessed up to 49 months

What was measured

Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months.

Groups in this outcome

RRx-001 + Platinum Doublet (A01-09)

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

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

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).

Investigator's Choice (A10)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
RRx-001 + Platinum Doublet (A01-09)89
RRx-001 + Platinum + RRx-001 (A10)10
Investigator's Choice (A10)2

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RRx-001 + Platinum Doublet (A01-09)32Not reportedNot reportedNot reportedNot reported
RRx-001 + Platinum + RRx-001 (A10)3Not reportedNot reportedNot reportedNot reported
Investigator's Choice (A10)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Overall Response Rate (ORR) will be defined as the proportion of patients with a CR or a PR per RECIST v1.1 based upon the best response as assessed; confirmation of response was not required, assessed up to 49 months.
groups
  1. description
    4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
    id
    OG000
    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
    OG001
    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
    OG002
    title
    Investigator's Choice (A10)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Assessed up to 49 months
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice