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NCT01964924 · ClinicalTrials.gov registry record · Phase 2

Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
37
Enrollment target

NCT01964924: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01964924 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01964924, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
37 participants
Enrollment target

Study Summary

This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 \[HER2/neu\] protein) that has spread to other places in the body. Trametinib and Akt inhibitor GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Trametinib
  • DRUG Akt Inhibitor GSK2141795

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2013-10-02
Est. Completion 2018-04-23
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01964924 record still lists

NCT01964924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01964924 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01964924 about?

NCT01964924 is a clinical study titled "Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer". This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epider...

What is the current status of trial NCT01964924?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2013-10-02. Estimated completion is 2018-04-23.

What interventions are being tested in trial NCT01964924?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Trametinib (DRUG), Akt Inhibitor GSK2141795 (DRUG).

Who is sponsoring clinical trial NCT01964924?

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

How this trial's enrollment target compares

Where NCT01964924's enrollment target sits among peer trials

37 1484th of 2000 higher than 505 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 NCT01964924, the US trial registry maintained by the National Library of Medicine. NCT01964924 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.