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NCT01835145 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 20
- Study locations
NCT01835145: Completed Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma, sponsored by National Cancer Institute (NCI).
NCT01835145 is a Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01835145, a Phase 2 study of Stage IV Uveal Melanoma AJCC v7 and Recurrent Uveal Melanoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
A patient will be declared a PFS4 success if they are on study and progression free for at least 4 months. Progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, with an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression. The success for each arm will be calculated independently as the number of successes divided by the total number of evaluable patie
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2013-07-31 |
| Est. Completion | 2019-11-01 |
| Phase | Phase 2 |
What the finished NCT01835145 record still lists
NCT01835145 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
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.
NCT01835145 names 20 study sites across 5 states, led by Delaware, Alaska, Florida.
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.
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).
Who is sponsoring clinical trial NCT01835145?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01835145's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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