CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 260 enrolled
Drug / intervention
Letrozole +7 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02101788
NCT02101788Phase 3Completed

A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK 1120212) in Patients With Recurrent or Progressive Low-Grade Serous Ovarian Cancer or Peritoneal Cancer

National Cancer Institute (NCI)·interventional·Posted Apr 2, 2014·Updated Nov 13, 2025

In Brief

A Phase 3 clinical trial evaluating Letrozole, Paclitaxel, and 6 other interventions for Borderline Ovarian Serous Tumor and 5 related conditions. Completed, enrolled 260 participants across 501 sites in 2 countries.

Detailed Summary

This phase II/III trial studies how well trametinib works and compares it to standard treatment with either letrozole, tamoxifen, paclitaxel, pegylated liposomal doxorubicin, or topotecan in treating patients with low-grade ovarian cancer or peritoneal cavity cancer that has come back (recurrent), become worse (progressive), or spread to other parts of the body. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective than standard therapy in treating patients with ovarian or peritoneal cavity cancer.

Study Details

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2, 2014
Enrollment StartApr 11, 2014
Primary CompletionApr 4, 2019
Study CompletionOct 27, 2025
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.3 years ago

Interventions

Letrozoledrug

Given PO

Paclitaxeldrug

Given IV

Pegylated Liposomal Doxorubicin Hydrochloridedrug

Given IV

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies

Tamoxifen Citratedrug

Given PO

Topotecandrug

Given IV

Trametinib Dimethyl Sulfoxidedrug

Given PO