Trial · NCT01989585
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Other | Fold changes in BRAF-mutation assay | Baseline to up to 4 weeks after last study treatment | Fold-changes in assay response will be calculated (post/pre). Fold changes in the assay will be compared across RECIST responses using the Kruskal-Wallis test. In addition, for assay-based response or progression, the proportions of patients with CR/partial response (PR), stable disease (SD), or progressive disease (PD) will be presented with exact 90% confidence intervals. Assay performance data will be compared with response. The proportions will be summarized and compared using exact confidence intervals. Behavior of the blood assay will be summarized graphically. |
| Other | Fold changes in tumor burden | Baseline to up to 4 weeks after last study treatment | Assay fold changes will be compared with fold changes in tumor burden (post/pre). The relationship will be summarized graphically and using the Spearman rank correlation. Differences in the behavior of the assay will be explored using a general linear model of log (fold-change) with study, baseline tumor burden, and log (fold-change tumor burden) as predictors. |
| Other | Pharmacokinetic parameters, including maximal plasma or serum concentration (Cmax), area under the curve to the last collection point (AUClast), area under the curve for dose interval (AUC0-t), and time of maximal concentration (Tmax) | Pre-treatment, 1, 2, 4, 6, 8, and 24 hours post-treatment on days 1 and 15 of cycle 1, and day 1 of cycles 2, 4, 8, and 12 (each cycle = 28 days) | Descriptive statistics including mean, standard deviation, coefficient of variation, geometric mean, median, minimum and maximum will be computed for each pharmacokinetic variable; descriptive statistics for natural-log transformed pharmacokinetic variables will also be provided. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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