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Protein Kinase Inhibitor
Navitoclax + Dabrafenib + Trametinib for Melanoma
Phase 1 & 2
Waitlist Available
Led By Ryan J Sullivan
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically confirmed, BRAF-mutant (V600E/K) melanoma (molecularly confirmed using validated, commercially available assay performed in a Clinical Laboratory Improvement Act [CLIA]-approved laboratory) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of a combination of dabrafenib, trametinib, and navitoclax to treat patients with BRAF mutant melanoma or solid tumors.
Who is the study for?
Adults with BRAF mutant melanoma that's spread or can't be surgically removed, who have good organ function and no recent significant bleeding or other serious illnesses. They must not have had certain treatments recently, agree to use non-hormonal birth control, and be able to swallow pills. Those with known allergies to the drugs being tested or similar compounds are excluded.Check my eligibility
What is being tested?
The trial is testing a combination of three drugs: dabrafenib, trametinib, and navitoclax for advanced melanoma with a specific mutation (BRAF V600E/K). It aims to find the best dose and see how well these drugs work together in stopping cancer growth by blocking enzymes and proteins needed by cancer cells.See study design
What are the potential side effects?
Potential side effects include fatigue, digestive issues like nausea or diarrhea, liver problems indicated by blood tests changes, skin reactions such as rash or dry skin, fever, high blood pressure, vision changes including blurred vision or reduced sharpness of vision.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is BRAF V600E/K mutant, cannot be surgically removed, and standard treatments have failed.
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I have a tumor that can be measured with scans or exams.
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I am fully active or able to carry out light work.
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I can take pills and don't have major gut issues affecting drug absorption.
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I am 18 years old or older.
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My kidney function is normal or only slightly reduced.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximal degree of tumor regression (Phase II)
Proportion of patients with a complete response (CR) (Phase II)
Recommended phase II dose of the combination of dabrafenib, trametinib, and navitoclax (Phase I)
Secondary outcome measures
Objective response rate (ORR) (Phase II)
Overall survival (OS) (Phase II)
Progression free survival (PFS) (Phase II)
Other outcome measures
Change in B-cell chronic lymphocytic leukemia/lymphoma 2 (BCL-2)
Change in Ki67
Change in phosphatase and tensin homolog (PTEN) status
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (dabrafenib, trametinib, and navitoclax)Experimental Treatment9 Interventions
Patients receive navitoclax PO QD days -7 to -1 of cycle 1 only. Patients also receive dabrafenib PO BID, trametinib PO QD, and navitoclax PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT, biopsy, and collection of blood samples throughout the trial.
Group II: Arm I (dabrafenib, trametinib)Experimental Treatment8 Interventions
ARM I: Patients receive dabrafenib PO BID and trametinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT, biopsy, and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
2014
Completed Phase 2
~1550
Navitoclax
2012
Completed Phase 2
~90
Biospecimen Collection
2004
Completed Phase 2
~1730
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Computed Tomography
2017
Completed Phase 2
~2720
Biopsy
2014
Completed Phase 4
~850
Dabrafenib
2011
Completed Phase 3
~4120
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,078 Total Patients Enrolled
557 Trials studying Melanoma
193,158 Patients Enrolled for Melanoma
Ryan J SullivanPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
22 Total Patients Enrolled
1 Trials studying Melanoma
22 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV-positive but not on any HIV medication that would interfere with the study drugs.Your blood clotting tests should be within the normal range.Your white blood cell count is equal to or greater than 3,000 per microliter.You must have a certain amount of a type of white blood cell called neutrophils in your blood.Your total bilirubin level should be within a certain range, and if it's a little high, it's okay if your direct bilirubin level is normal.I have not taken navitoclax, BRAF, or MEK inhibitors.My brain metastasis has been stable for 3+ months without steroids.I haven't had cancer treatments like immunotherapy or chemotherapy in the last 14 to 30 days.I have been cancer-free for at least 3 years, or my only other cancer was non-melanoma skin cancer that was completely removed.I am allergic to navitoclax, dabrafenib, trametinib, their ingredients, or DMSO.I have had interstitial lung disease or pneumonitis.My high blood pressure is not controlled by medication.I have or had hepatitis B or C.I have a condition that makes me bleed easily or I am currently experiencing significant bleeding.I am not taking strong medications like ketoconazole or clarithromycin before starting or during navitoclax treatment.I am fully active or able to carry out light work.I had bleeding not caused by chemotherapy in the last year.I don't have ongoing major side effects from cancer treatment, except for hair loss or hormone issues.I am not taking certain blood thinners or pain relievers that could interfere with my treatment.I am not taking any herbal supplements.I have had previous cancer treatments but haven't used navitoclax for more than a week.My melanoma is BRAF V600E/K mutant, cannot be surgically removed, and standard treatments have failed.I have a tumor that can be measured with scans or exams.I can take pills and don't have major gut issues affecting drug absorption.I can understand and am willing to sign the consent form, or I have someone legally authorized to do so on my behalf.My test for BRAF mutation in melanoma was done with a method not approved by the FDA.I may have had immunotherapy or chemotherapy, but not treatments with navitoclax, BRAF, or MEK inhibitors.I do not have any serious ongoing illnesses that would stop me from following the study's requirements.I am not pregnant or breastfeeding.My hemoglobin level is at least 9 g/dl.I agree to use non-hormonal birth control or abstain from sex during and for 4 months after the study.I have a history of G6PD deficiency.I am not taking any strong medication that affects liver enzymes or certain cancer drugs.I am 18 years old or older.You are expected to live for at least 3 more months.Your heart's electrical activity (called QTc interval) should be less than 480 milliseconds.I am not currently using any medication that is not allowed in the study.I have or am at risk for eye conditions like RVO or CSR.I have a history of heart problems.I have not taken navitoclax for more than 7 days unless I had to stop due to reasons other than side effects or my disease getting worse.My heart valve condition is not severe, with only mild issues allowed.Your heart's pumping function is within the normal range on an echocardiogram.You have enough platelets in your blood.My kidney function is normal or only slightly reduced.Your AST and ALT levels in your blood are not more than 2.5 times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (dabrafenib, trametinib, and navitoclax)
- Group 2: Arm I (dabrafenib, trametinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have there been any prior experiments that evaluated the effects of Pharmacological Study?
"At present, there are 8 Phase 3 trials and a total of 105 active studies for Pharmacological Study. While predominantly situated in Athens and Chiba, the research is spread across 6576 locations worldwide."
Answered by AI
Does this experimental research represent a groundbreaking approach in its field?
"Presently, there are 105 active clinical trials related to pharmacology being conducted in 1297 cities and 45 countries. These tests began with the AbbVie (previously Abbott) sponsored trial of 29 participants back in 2009 that completed its first stage of drug approval. Subsequently, 694 more experiments have been finalized since then."
Answered by AI
Are there numerous North American sites that are facilitating this clinical trial?
"The University of Kansas Cancer Center in Kansas City, HaysMed University of Kansas Health System in Hays, and Lawrence Memorial Hospital in Lawrence are just a few examples from the 18 different clinical sites enrolled to participate."
Answered by AI
Is enrollment actively open for this research experiment?
"This trial has closed its participant recruitment, with the original post dating back to October 25th 2013 and the last edit occurring on November 29th 2022. If you are seeking a medical study, there are currently 909 studies that actively seek patients with metastatic melanoma and 105 trials for Pharmacological Study in progress."
Answered by AI
What is the capacity of this research project?
"Sadly, enrollment for this clinical trial has been closed. Its first posting was made on October 25th 2013 and its last update took place November 29th 2022. However, there are 909 trials actively recruiting patients suffering from metastatic melanoma and 105 studies seeking participants to participate in a Pharmacological Study."
Answered by AI
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