Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
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|ClinicalTrials.gov Identifier: NCT02034110|
Recruitment Status : Recruiting
First Posted : January 13, 2014
Last Update Posted : January 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Dabrafenib Drug: Trametinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib|
|Actual Study Start Date :||March 12, 2014|
|Estimated Primary Completion Date :||June 29, 2020|
|Estimated Study Completion Date :||August 3, 2020|
Experimental: Dabrafenib + Trametinib
Subjects will receive Dabrafenib 150 mg twice daily orally plus Trametinib 2 mg once daily orally on a continuous basis. Dabrafenib will be administered under fasted conditions, either 1 hour (hr) before or 2 hours (hrs) after a meal with approximately 200 mL of water with an interval of 12 hours. Trametinib will be administered under fasted conditions, either 1 hr before or 2 hrs after a meal with approximately 200 mL of water. Subjects will take their dose of Trametinib concurrently with the morning dose of Dabrafenib. A treatment cycle is 28 days in duration. Subjects will continue treatment until an unacceptable toxicity, disease progression, or death occurs.
Dabrafenib is a 150 mg twice daily capsule administered orally on a continuous basis.Drug: Trametinib
Trametinib is a 2 mg once daily tablet administered orally on a continuous basis.
- Overall response rate (ORR) [ Time Frame: Possibly up to Week 208 ]To determine the ORR as measured radiographically via Response Evaluation Criteria in Solid tumors (RECIST) version 1.1 for solid tumor histologies or established response criteria for specific hematologic malignancies.
- Duration of response [ Time Frame: From the time of first documented evidence of CR or PR until the first documented sign of disease progression or death (approximately up to Week 208) ]Duration of response is defined as the subset of subjects who show a confirmed clinical response (CR) or partial response (PR), the time from first documented evidence of CR or PR until the first documented sign of disease progression or death.
- Investigator-assessed Progression-free survival (PFS) [ Time Frame: Possibly up to Week 208 ]PFS is defined as the time from the date of enrollment to the earliest date of progression or death.
- Overall Survival (OS) [ Time Frame: Until death or lost to follow-up (approximately up to Week 208) ]OS is defined as the time from the date of enrollment to the date of death due to any cause.
- Change from baseline in physical examination findings [ Time Frame: Possibly up to Week 208 ]Examination will include assessments of the head and neck, eyes, ears, nose, throat, skin, thyroid, neurological, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, extremities and genitalia. Height (measured only at Screening) and weight will be measured and recorded. Complete physical examinations will also include thorough rectal and genitourinary (pelvic) examinations to assess secondary malignancies.
- Change from baseline in vital signs [ Time Frame: Possibly up to Week 208 ]Vital sign measurements will include systolic and diastolic blood pressure, temperature, pulse rate and respiratory rate
- Number of subjects with Adverse events (AEs) [ Time Frame: Possibly up to Week 208 ]AE is any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Change from baseline in laboratory values [ Time Frame: Possibly up to Week 208 ]Laboratory assessments include haematology, clinical chemistry, urinalysis, coagulation and histology-specific tests
- Change from baseline in cardiac assessments [ Time Frame: Possibly up to Week 208 ]Cardiac assessments include Electrocardiogram (ECG) and Echocardiograms (ECHOs)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034110
|Contact: Novartis Pharmaceuticals||1-888-669-6682||Novartis.email@example.com|
|Contact: Novartis Pharmaceuticals|
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|