Cabozantinib-S-Malate and Vemurafenib in Treating Patients With Solid Tumors or Melanoma That is Metastatic or That Cannot Be Removed By Surgery

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01835184
Phase
PHASE1
Status
Terminated

Conditions

  • Recurrent Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • cabozantinib-s-malate — DRUG
    Given PO
  • vemurafenib — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

This phase I trial studies the side effects and best dose of cabozantinib-s-malate when given together with vemurafenib in treating patients with solid tumors or melanoma that is metastatic or that cannot be removed by surgery. Cabozantinib-s-malate and vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
May 31, 2013
Status verified
Sep 2014
Primary completion
Sep 30, 2014

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cabozantinib-s-malate, vemurafenib)
    Patients receive cabozantinib-s-malate PO QD and vemurafenib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerable dose of cabozantinib-s-malate in combination with vemurafenib based on the incidence of dose-limiting toxicity (DLT) graded according to the National Cancer Institute CTCAE version 4.0. [ Time Frame: 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University/Winship Cancer InstituteAtlantaGeorgia30322-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Atlanta, GA

By research site
Emory University/Winship Cancer Institute· Atlanta, GADana-Farber Cancer Institute· Boston, MAVirginia Commonwealth University· Richmond, VA

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