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NCT01989585 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma
A Phase 1 study of Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
- 20
- Study locations
NCT01989585: Active Phase 1 study of Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by National Cancer Institute (NCI).
NCT01989585 is a Phase 1 study of Malignant Solid Neoplasm and Metastatic Melanoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 75 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989585, a Phase 1 study of Malignant Solid Neoplasm and Metastatic Melanoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of tumor cells by blocking Bcl-2, a protein needed for tumor cell survival. Giving navitoclax, dabrafenib, and trametinib may help shrink tumors in patients with melanoma.
Primary Outcome
Determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- DRUG Dabrafenib
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
- Moffitt Cancer Center - McKinley Campus - Tampa
- Moffitt Cancer Center - Tampa
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC Norris Oncology/Hematology-Newport Beach - Newport Beach
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Northwestern University - Chicago
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2014-03-24 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT01989585 still lists
NCT01989585 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT01989585 names 20 study sites across 7 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01989585 about?
NCT01989585 is a clinical study titled "Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma". This phase I/II trial studies the side effects and best dose of dabrafenib, trametinib, and navitoclax and to see how well they work in treating patients with BRAF mutant melanoma or solid tumors that has spread from where it first started (primary site) to other places in the body (metastatic) or c...
What is the current status of trial NCT01989585?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2014-03-24. Estimated completion is 2027-12-31.
What conditions does trial NCT01989585 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Metastatic Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8, Unresectable Melanoma, Clinical Stage III Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT01989585?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT01989585?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01989585 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01989585's enrollment target sits among peer trials
75 105th of 176 higher than 72 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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