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COMPLETED Phase 2

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

NCT01835145 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Cabozantinib S-malate
  • OTHER Laboratory Biomarker Analysis
  • DRUG Temozolomide
  • DRUG Dacarbazine

Study Locations (20)

Delaware

  • Beebe Medical Center — Lewes
  • Christiana Gynecologic Oncology LLC — Newark
  • Delaware Clinical and Laboratory Physicians PA — Newark
  • Helen F Graham Cancer Center — Newark
  • Medical Oncology Hematology Consultants PA — Newark
  • Christiana Care Health System-Christiana Hospital — Newark
  • Beebe Health Campus — Rehoboth Beach
  • TidalHealth Nanticoke / Allen Cancer Center — Seaford
  • Christiana Care Health System-Wilmington Hospital — Wilmington

Alaska

  • Anchorage Radiation Therapy Center — Anchorage
  • Alaska Breast Care and Surgery LLC — Anchorage
  • Alaska Oncology and Hematology LLC — Anchorage
  • Alaska Women's Cancer Care — Anchorage
  • Anchorage Oncology Centre — Anchorage
  • Katmai Oncology Group — Anchorage
  • Providence Alaska Medical Center — Anchorage

Florida

  • Holy Cross Hospital — Fort Lauderdale
  • Jupiter Medical Center — Jupiter

Alabama

  • University of Alabama at Birmingham Cancer Center — Birmingham

California

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2013-07-31
Est. Completion 2019-11-01
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01835145

The ClinicalTrials.gov registry entry for NCT01835145 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Stage IV Uveal Melanoma AJCC v7 appearing as the primary indexed condition, and to 4 interventions — of which Cabozantinib S-malate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01835145 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Delaware, Alaska, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01835145 about?

NCT01835145 is a clinical study titled "Cabozantinib-S-Malate Compared With Temozolomide or Dacarbazine in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed by Surgery". 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...

What is the current status of trial NCT01835145?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2013-07-31. Estimated completion is 2019-11-01.

What conditions does trial NCT01835145 study?

This clinical trial studies the following conditions: Stage IV Uveal Melanoma AJCC v7, Recurrent Uveal Melanoma, Stage III Uveal Melanoma AJCC v7, Stage IIIA Uveal Melanoma AJCC v7, Stage IIIB Uveal Melanoma AJCC v7. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01835145?

The interventions under investigation include: Cabozantinib S-malate (DRUG), Laboratory Biomarker Analysis (OTHER), Temozolomide (DRUG), Dacarbazine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01835145?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01835145 being conducted?

This trial has 20 study locations across Alabama, Alaska, California, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial