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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02097225
Phase
PHASE1
Status
Terminated

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Onalespib — DRUG
    Given IV
  • Pharmacological Study — OTHER
    Correlative studies
  • Trametinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
May 29, 2014
Status verified
Sep 2024
Primary completion
Mar 31, 2019
Completion
Oct 26, 2022

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose level -1 (dabrafenib, trametinib, onalespib)
    Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28, and onalespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. There are four dose levels, plus a fallback dose. Dose escalation begins at dose level 1 (starting dose). Fallback dose level -1 is initiated if more than 1 of 6 subjects in dose level 1 (starting dose) develop DLTs. Dose Level -1 (fallback dose): * Dabrafenib = 75 mg * Trametinib = 1 mg * Onalespib = 180 mg/m\^2
  • Experimental: Dose level 1 (dabrafenib, trametinib, onalespib)
    Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28, and onalespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. There are four dose levels, plus a fallback dose. Dose escalation begins at dose level 1 (starting dose). Dose Level 1 (starting dose): * Dabrafenib = 150 mg * Trametinib = 1 mg * Onalespib = 180 mg/m\^2
  • Experimental: Dose level 2 (dabrafenib, trametinib, onalespib)
    Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28, and onalespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. There are four dose levels, plus a fallback dose. Dose escalation begins at dose level 1 (starting dose). Dose Level 2: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 180 mg/m\^2
  • Experimental: Dose level 3 (dabrafenib, trametinib, onalespib)
    Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28, and onalespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. There are four dose levels, plus a fallback dose. Dose escalation begins at dose level 1 (starting dose). Dose Level 3: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 220 mg/m\^2
  • Experimental: Dose level 4 (dabrafenib, trametinib, onalespib)
    Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28, and onalespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. There are four dose levels, plus a fallback dose. Dose escalation begins at dose level 1 (starting dose). Dose Level 4: * Dabrafenib = 150 mg * Trametinib = 2 mg * Onalespib = 260 mg/m\^2

Primary Outcome Measure

Maximum Tolerated Dose of Dabrafenib [ Time Frame: 28 days after start of treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

Related Studies