Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 38
Summary
- 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
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 es...
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.
Tracking Information
- NCT #
- NCT02097225
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ryan J Sullivan Massachusetts General Hospital
Get Well Soon