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NCT01979523 · ClinicalTrials.gov registry record · Phase 2

Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma

A Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
42
Enrollment target
7
Study locations

NCT01979523: Active Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma, sponsored by National Cancer Institute (NCI).

NCT01979523 is a Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01979523, a Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
42 participants
Enrollment target
7
Study locations

Study Summary

This randomized phase II trial studies how well trametinib with or without Akt inhibitor GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to other parts of the body (metastatic). Trametinib and GSK2141795 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 with or without GSK2141795 in treating patients with metastatic uveal melanoma.

Primary Outcome

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Trametinib
  • OTHER Pharmacological Study
  • DRUG Uprosertib

Study Locations (7)

New York

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Other

  • Institut Curie Paris - Paris
  • The University of Liverpool - Liverpool

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta

Tennessee

  • Vanderbilt University/Ingram Cancer Center - Nashville

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2013-11-21
Est. Completion 2026-07-02
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT01979523 still lists

NCT01979523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).

The record links to 2 conditions, with Stage IV Uveal Melanoma AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01979523 lists 7 locations in 5 states (New York, Other, Georgia).

Frequently Asked Questions

What is clinical trial NCT01979523 about?

NCT01979523 is a clinical study titled "Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma". This randomized phase II trial studies how well trametinib with or without Akt inhibitor GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to other parts of the body (metastatic). Trametinib and GSK2141795 may stop the growth of tumor cells by blocking some of th...

What is the current status of trial NCT01979523?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2013-11-21. Estimated completion is 2026-07-02.

What conditions does trial NCT01979523 study?

This clinical trial studies the following conditions: Stage IV Uveal Melanoma AJCC v7, Recurrent Uveal Melanoma.

What interventions are being tested in trial NCT01979523?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Trametinib (DRUG), Pharmacological Study (OTHER), Uprosertib (DRUG).

Who is sponsoring clinical trial NCT01979523?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01979523 being conducted?

This trial has 7 study locations across Georgia, New York, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stage IV Uveal Melanoma AJCC v7

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01979523's enrollment target sits among peer trials

42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01979523, the US trial registry maintained by the National Library of Medicine. NCT01979523 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.