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NCT02489903 · OUTCOME

Progression Free Survival (PFS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Assessed up to 49 months

What was measured

Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, 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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RRx-001 + Platinum Doublet (A01-09)5.87Not reported4.467.54Not reported
RRx-001 + Platinum + RRx-001 (A10)6.50Not reportedNANAinsufficient number of participants with events
Investigator's Choice (A10)12Not reportedNANAinsufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.46
        upper Limit
        7.54
        value
        5.87
      2. comment
        insufficient number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        6.50
      3. comment
        insufficient number of participants with events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Progression-free survival (PFS) will be defined as the elapsed time from the from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 49 months.
dispersion Type
95% Confidence Interval
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
MEDIAN
reporting Status
POSTED
time Frame
Assessed up to 49 months
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice