Trial · NCT01989585
Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma
NCT01989585, Phase 1, Phase 2, Active not recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma. Trials, record NCT01989585. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01989585
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma
- NCT number
- NCT01989585
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 75 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Malignant Solid Neoplasm, Metastatic Melanoma, Unresectable Melanoma
- Interventions
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Dabrafenib, Echocardiography Test, Laboratory Biomarker Analysis, Magnetic Resonance Imaging, Multigated Acquisition Scan, Navitoclax, Pharmacological Study, Trametinib
- First posted
- 2013-11-21
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose of the combination of dabrafenib, trametinib, and navitoclax (Phase I) | Up to 28 days | Determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. |
| Primary | Proportion of patients with a complete response (CR) (Phase II) | Up to 4 weeks after last study treatment | Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, in the cohort of patients treated with dabrafenib, trametinib, and navitoclax (DTN). The proportion of patients with a best response of CR will be presented with a 95% confidence interval calculated using the method of Atkinson and Brown. |
| Primary | Maximal degree of tumor regression (Phase II) | Up to 4 weeks after last study treatment | A comparison between the maximal tumor regression for patients treated with DTN and dabrafenib and trametinib (DT) will be conducted using a Wilcoxon rank-sum test. |
| Secondary | Progression free survival (PFS) (Phase II) | Time from start of treatment to time of progression or death, whichever occurs first, assessed for up to 10 years | PFS will be summarized using the Kaplan-Meier. Log-rank tests will be used to assess for indications of differences between the two treatment modalities. |
| Secondary | Overall survival (OS) (Phase II) | Up to 10 years | OS will be summarized using the Kaplan-Meier. Log-rank tests will be used to assess for indications of differences between the two treatment modalities. |
| Secondary | Objective response rate (ORR) (Phase II) | Up to 4 weeks after last study treatment | ORRs will be presented with 95% exact, binomial confidence intervals. |
| Other | Change in terminal deoxynucleotidyl transferase 2´-deoxyuridine, 5´-triphosphate (dUTP) nick end labeling assay (TUNEL) staining | Baseline to up to 1 week | Fold changes of TUNEL will be calculated (post/pre). A Wilcoxon rank-sum test will be used to compare the ratios (or equivalently, the difference in the natural logs) of baseline and follow-up levels of TUNEL between DTN and DT treatment arms. |
| Other | Change in B-cell chronic lymphocytic leukemia/lymphoma 2 (BCL-2) | Baseline to up to 1 week | Will be primarily descriptive. |
| Other | Change in Ki67 | Baseline to up to 1 week | Will be primarily descriptive. |
| Other | Change in phosphatase and tensin homolog (PTEN) status | Baseline to up to 1 week | Will be primarily descriptive. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40721981 | DERIVED |
Source PubMed
Grants5
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UM1CA186688 | Texas EXperimental Cancer Therapeutics Network - TEX CTN | MERIC-BERNSTAM, FUNDA; SARANTOPOULOS, JOHN; YAO, JAMES C | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186709 | Dana-Farber/Harvard Cancer Center Experimental Therapeutics Clinical Trials Network Site (DF/HCC ETCTN Site) | SHAPIRO, GEOFFREY I.; FLAHERTY, KEITH T; KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
| UM1CA186716 | Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics | JABBOUR, SALMA; LIU, GLENN | RBHS -CANCER INSTITUTE OF NEW JERSEY | NATIONAL CANCER INSTITUTE | 2014 to 2019 | NIH RePORTER |
| U01CA062490 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis | KUFE, DONALD W. | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 1994 to 2013 | NIH RePORTER |
| U01CA132194 | Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis (U01) | DIPAOLA, ROBERT S. | RBHS -CANCER INSTITUTE OF NEW JERSEY | NATIONAL CANCER INSTITUTE | 2008 to 2013 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01989585
GET https://conductscience.org/api/trials/v1/NCT01989585/registered