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NCT02101788 · OUTCOME

Objective Tumor Response Rate (Complete Response and Partial Response)

Trametinib in Treating Patients With Recurrent or Progressive Low-Grade Ovarian Cancer or Peritoneal Cavity Cancer · Source last updated 2026-08-04

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B

What was measured

The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.

Analysis population: Randomized patients

Groups in this outcome

Arm A - Control Arm

Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days

Arm B - Experimental Arm

Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days

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

Analysis denominator · Participants

GroupSource count
Arm A - Control Arm130
Arm B - Experimental Arm130

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A - Control Arm8Not reportedNot reportedNot reportedNot reported
Arm B - Experimental Arm34Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        34
denoms
  1. counts
    1. group Id
      OG000
      value
      130
    2. group Id
      OG001
      value
      130
    units
    Participants
description
The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria.
groups
  1. description
    Investigators choice of Letrozole 2.5 mg po qd continuously, tamoxifen 20mg po bid continuously, paclitaxel 80mg/m2 IV over 1 hr on day 1q 7d, 3 wks on, 1 wk off, Pegylated Liposomal Doxorubicin 40 or 50mg/m2 IV over 1 hr on day 1 q. 28d, Topotecan 4.0mg/m2 over 30 min on day 1,8 and 15 of a 28 day cycle. For each arm, 1 cycle - 28 days
    id
    OG000
    title
    Arm A - Control Arm
  2. description
    Trametinib 2 mg po daily continuous treatment, For each arm, 1 cycle = 28 days
    id
    OG001
    title
    Arm B - Experimental Arm
param Type
NUMBER
population Description
Randomized patients
reporting Status
POSTED
time Frame
Time from study entry to time of progression or death, an average of 7 months for arm A and 13 months for arm B
title
Objective Tumor Response Rate (Complete Response and Partial Response)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice