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Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery

NCT01835145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2022-08-04

Study results available
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Summary

This randomized phase II trial studies how well cabozantinib-s-malate works compared with temozolomide or dacarbazine in treating patients with melanoma of the eye (ocular melanoma) that has spread to other parts of the body and cannot be removed by surgery. Cabozantinib-s-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cabozantinib-s-malate works better than temozolomide or dacarbazine in treating patients with melanoma of the eye.

Conditions

  • Recurrent Uveal Melanoma
  • Stage III Uveal Melanoma AJCC v7
  • Stage IIIA Uveal Melanoma AJCC v7
  • Stage IIIB Uveal Melanoma AJCC v7
  • Stage IIIC Uveal Melanoma AJCC v7
  • Stage IV Uveal Melanoma AJCC v7

Interventions

DRUG

Cabozantinib S-malate

Given PO

DRUG

Dacarbazine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Temozolomide

Given PO

Sponsors & Collaborators

  • Exelisis

    collaborator UNKNOWN

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Jason J Luke · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-10-21
Completion
2019-11-01

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835145 on ClinicalTrials.gov