Spots Global Cancer Trial Database for Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

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Trial Identification

Brief Title: Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Official Title: Phase I Study of AT13387 in Combination With Dabrafenib and Trametinib in Patients With BRAF-Mutant Melanoma and Other Solid Tumors

Study ID: NCT02097225

Conditions

BRAF V600E Mutation Present

BRAF V600K Mutation Present

Metastatic Malignant Solid Neoplasm

Metastatic Melanoma

Stage III Cutaneous Melanoma AJCC v7

Stage IIIA Cutaneous Melanoma AJCC v7

Stage IIIB Cutaneous Melanoma AJCC v7

Stage IIIC Cutaneous Melanoma AJCC v7

Stage IV Cutaneous Melanoma AJCC v6 and v7

Unresectable Solid Neoplasm

Interventions

Dabrafenib

Laboratory Biomarker Analysis

Onalespib

Pharmacological Study

Trametinib

Study Description

Brief Summary: This phase I trial studies the side effects and best dose of onalespib when given together with dabrafenib and trametinib in treating patients with BRAF-mutant melanoma or solid tumors that have spread to another place in the body (metastatic) or cannot be removed by surgery. Onalespib, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD), toxicity, and safety profile of onalespib (AT13387) given weekly in combination with dabrafenib and trametinib in patients with BRAF-mutant metastatic or unresectable solid tumors. SECONDARY OBJECTIVES: I. To obtain preliminary estimates of the objective response rate (ORR) and progression-free survival (PFS) and document the 6-month PFS and 1-year overall survival (OS) of patients with BRAF-mutant metastatic or unresectable melanoma treated with AT13387 given weekly in combination with dabrafenib and trametinib. II. To describe the pharmacokinetics of treatment with dabrafenib, trametinib, and AT13387. OUTLINE: This is a dose-escalation study of onalespib. Patients receive dabrafenib orally (PO) twice daily (BID), trametinib PO once daily (QD) on days 1-28, and onalespib intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 28 days and every 6 months for up to 2 years.