Trials / Terminated
TerminatedNCT01835184
Cabozantinib-S-Malate and Vemurafenib in Treating Patients With Solid Tumors or Melanoma That is Metastatic or That Cannot Be Removed By Surgery
Phase I Dose Escalation of the MET Inhibitor XL184 and the BRAF Inhibitor Vemurafenib
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
PRIMARY OBJECTIVES: I. To determine a tolerable dose of XL184 (cabozantinib-s-malate) in combination with vemurafenib. SECONDARY OBJECTIVES: I. To determine the objective response rate (ORR) and disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. II. To determine the progression-free survival (PFS). III. To determine the response rate according to the molecular phenotype. OUTLINE: This is a dose-escalation study of cabozantinib-s-malate. Patients receive cabozantinib-s-malate orally (PO) once daily (QD) and vemurafenib PO twice daily (BID) 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 for 4 weeks.
Conditions
- Recurrent Melanoma
- Stage IIIA Melanoma
- Stage IIIB Melanoma
- Stage IIIC Melanoma
- Stage IV Melanoma
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cabozantinib-s-malate | Given PO |
| DRUG | vemurafenib | Given PO |
| OTHER | laboratory biomarker analysis | Correlative studies |
| OTHER | pharmacological study | Correlative studies |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-09-01
- First posted
- 2013-04-18
- Last updated
- 2014-09-25
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01835184. Inclusion in this directory is not an endorsement.