NCT01964924

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

A Single Arm, Phase II Study of Single Agent Trametinib Followed by Trametinib in Combination With GSK2141795 in Patients With Advanced Triple Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the anti-tumor activity associated with trametinib monotherapy in patients with triple negative breast cancer (TNBC). SECONDARY OBJECTIVES: I. To assess the anti-tumor activity associated with trametinib in combination with AKT inhibitor GSK2141795 after progression on trametinib in patients with metastatic TNBC. II. To determine the progression-free survival following the initiation of treatment with trametinib monotherapy in patients with metastatic TNBC. III. To determine the progression-free survival following the initiation of treatment with trametinib in combination with GSK2141795 in patients with metastatic TNBC. IV. To determine the overall survival following the initiation of treatment with trametinib with GSK214179 in patients with metastatic TNBC. V. To determine the nature and degree of toxicities associated with trametinib monotherapy and trametinib in combination with GSK2141795 in patients with metastatic TNBC. VI. To determine the biomarker potential of phosphatase and tensin homolog (PTEN) to predict response to single agent trametinib. VII. To determine molecular markers of sensitivity and resistance to trametinib monotherapy and trametinib in combination with GSK2141795 in patients with metastatic TNBC. OUTLINE: PART 1: Patients receive trametinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression continue to Part 2. PART 2: Patients receive trametinib as in Part 1 and also receive Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 52 weeks.

Conditions

• Estrogen Receptor Negative
• HER2/Neu Negative
• Invasive Breast Carcinoma
• Progesterone Receptor Negative
• Recurrent Breast Carcinoma
• Stage IV Breast Cancer
• Triple-Negative Breast Carcinoma

Interventions

Type	Name	Description
DRUG	Akt Inhibitor GSK2141795	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Trametinib	Given PO

Timeline

• Start date: 2013-10-02
• Primary completion: 2017-01-20
• Completion: 2018-04-23
• First posted: 2013-10-17
• Last updated: 2019-09-20
• Results posted: 2019-09-20

Locations

8 sites across 1 country: United States