SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT04390243

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

BrafPanc: A Phase II Trial of Binimetinib in Combination With Encorafenib in Patients With Pancreatic Malignancies and a Somatic BRAFV600E Mutation

This phase II trial studies the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation.

NCT04390243 Locally Advanced Pancreatic Carcinoma Metastatic Pancreatic Carcinoma Recurrent Pancreatic Carcinoma Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8
MeSH:Carcinoma Pancreatic Neoplasms
HPO:Carcinoma Neoplasm of the pancreas

2 Interventions

Name: Binimetinib

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (encorafenib, binimetinib)

Name: Encorafenib

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (encorafenib, binimetinib)


Primary Outcomes

Description: An objective response is defined as a complete or partial response with a confirmation scan not less than 4 weeks after the initial scan. Disease status will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria. The final ORR point estimate and corresponding 95% confidence interval will be reported.

Measure: Objective response rate (ORR)

Time: At 24 weeks

Secondary Outcomes

Description: Progression-free survival is defined as the time from registration to clinical or radiographic disease progression or death, whichever occurs first, as defined by RECIST 1.1 criteria. PFS will be estimated using the Kaplan-Meier method. The median PFS and corresponding 95% confidence interval will be reported.

Measure: Progression-free survival (PFS)

Time: From registration to the first of either disease progression or death from any cause, assessed up to 5 years

Description: Overall survival (OS) is defined as the time from registration to death from any cause. OS will be estimated using the Kaplan-Meier method. The median overall survival and corresponding 95% confidence interval will be reported.

Measure: Overall survival

Time: From registration to death from any cause, assessed up to 5 years

Description: Duration of response is defined as the duration of time from first documentation of an objective response to the earliest date disease progression is documented or death from any cause. Duration of response will be estimated using the Kaplan-Meier method. The median duration of response and corresponding 95% confidence interval will be reported.

Measure: Duration of response

Time: From first documentation of an objective response to the earliest date disease progression is documented or death from any cause, assessed up to 5 years

Description: Time to response is defined as the duration of time from registration to the first documentation of an objective response. Time to response will be estimated using the Kaplan-Meier method. The median time to response and corresponding 95% confidence interval will be reported.

Measure: Time to response

Time: From registration to the first documentation of an objective response, assessed up to 5 years

Description: Adverse Events as defined by National Institute of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. All patients who have initiated treatment will be considered evaluable for adverse event analyses. The rate of patients experiencing a grade 3+ adverse event will be reported.

Measure: Incidence of adverse events

Time: Up to 5 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation This phase II trial studies the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. --- V600E ---

Binimetinib and Encorafenib for the Treatment of Pancreatic Cancer in Patients With a Somatic BRAF V600E Mutation This phase II trial studies the side effects and how well the combination of binimetinib and encorafenib work in treating patients with pancreatic cancer with a somatic BRAF V600E mutation. --- V600E --- --- V600E ---

Giving binimetinib and encorafenib may work better compared to the usual treatment in treating patients with pancreatic cancer and a somatic BRAF V600E mutation. --- V600E ---

The rate of patients experiencing a grade 3+ adverse event will be reported.. Inclusion Criteria: - PRE-REGISTRATION: - Histological confirmation of a pancreatic malignancy as confirmed by the local pathology lab - Patients whose disease has progressed on (or who were intolerant of) at least one line of therapy for metastatic disease - Patients whose disease has recurred with metastatic disease =< 12 weeks of completion of neoadjuvant or adjuvant systemic chemotherapy; or patients with locally advanced disease whose disease progressed to metastatic disease on, or =< 12 weeks after completion of systemic chemotherapy would also be eligible - Provide informed written consent =< 28 days prior to pre-registration - Central electronic/paper confirmation of the presence of a BRAF V600E mutation. --- V600E ---

Results from a Clinical Laboratory Improvement Act (CLIA)/College of American Pathologists (CAP) certified testing lab (commercial or institutional) that confirm the presence of a BRAF V600E mutation in the patient's tumor must be submitted for central review - REGISTRATION: NOTE: Registration must occur =< 30 days after pre-registration - Confirmation of the presence of BRAF V600E mutation in the patient's tumor - Measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United [ACCRU] web site) - Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to registration) - Platelet count >= 75,000/mm^3 (obtained =< 14 days prior to registration) - Hemoglobin >= 9.0 g/dL (obtained =< 14 days prior to registration) - Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration) - Aspartate transaminase (AST) =< 2.5 x ULN; in participants with liver metastases =< 5 x ULN (obtained =< 14 days prior to registration) - Aminotransferase (ALT) =< 2.5 x ULN; in participants with liver metastases =< 5 x ULN (obtained =< 14 days prior to registration) - Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft Gault formula (obtained =< 14 days prior to registration) - Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only - Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study). --- V600E ---

Results from a Clinical Laboratory Improvement Act (CLIA)/College of American Pathologists (CAP) certified testing lab (commercial or institutional) that confirm the presence of a BRAF V600E mutation in the patient's tumor must be submitted for central review - REGISTRATION: NOTE: Registration must occur =< 30 days after pre-registration - Confirmation of the presence of BRAF V600E mutation in the patient's tumor - Measurable disease - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2. (Form is available on the Academic and Community Cancer Research United [ACCRU] web site) - Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 14 days prior to registration) - Platelet count >= 75,000/mm^3 (obtained =< 14 days prior to registration) - Hemoglobin >= 9.0 g/dL (obtained =< 14 days prior to registration) - Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 14 days prior to registration) - Aspartate transaminase (AST) =< 2.5 x ULN; in participants with liver metastases =< 5 x ULN (obtained =< 14 days prior to registration) - Aminotransferase (ALT) =< 2.5 x ULN; in participants with liver metastases =< 5 x ULN (obtained =< 14 days prior to registration) - Calculated creatinine clearance must be >= 45 ml/min using the Cockcroft Gault formula (obtained =< 14 days prior to registration) - Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only - Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study). --- V600E --- --- V600E ---

Note: During the active monitoring phase of a study (i.e., active treatment), participants must be willing to return to the consenting institution for follow-up - Ability to swallow the investigational product tablets and capsules - Willing to provide tissue and blood samples for correlative research purposes Exclusion Criteria: - REGISTRATION: - Patients whose tumor harbors a BRAF non-V600E mutation or a BRAF fusion - Prior therapy with BRAF inhibitor (e.g., encorafenib, dabrafenib, vemurafenib) and/or a MEK inhibitor (e.g., binimetinib, trametinib, cobimetinib) - Known hypersensitivity or contraindication to any component of binimetinib or encorafenib or their excipients - Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception - NOTE: Female participants of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, and to not donate ova from screening until 30 days after the last dose of study drug - NOTE: Male participants must agree to use methods of contraception that are highly effective or acceptable, and to not donate sperm from screening until 90 days after the last dose of study drug - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens - Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy. --- V600E ---

- NOTE: Patients with no prior history of HBV infection who have been vaccinated against HBV and who have a positive antibody against hepatitis B surface antigen as the only evidence of prior exposure may register Inclusion Criteria: - PRE-REGISTRATION: - Histological confirmation of a pancreatic malignancy as confirmed by the local pathology lab - Patients whose disease has progressed on (or who were intolerant of) at least one line of therapy for metastatic disease - Patients whose disease has recurred with metastatic disease =< 12 weeks of completion of neoadjuvant or adjuvant systemic chemotherapy; or patients with locally advanced disease whose disease progressed to metastatic disease on, or =< 12 weeks after completion of systemic chemotherapy would also be eligible - Provide informed written consent =< 28 days prior to pre-registration - Central electronic/paper confirmation of the presence of a BRAF V600E mutation. --- V600E ---

- NOTE: Patients with no prior history of HBV infection who have been vaccinated against HBV and who have a positive antibody against hepatitis B surface antigen as the only evidence of prior exposure may register Locally Advanced Pancreatic Carcinoma Metastatic Pancreatic Carcinoma Recurrent Pancreatic Carcinoma Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Carcinoma Pancreatic Neoplasms PRIMARY OBJECTIVE: I. To determine the efficacy of the combination of binimetinib and encorafenib as >= 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation. --- V600E ---

SECONDARY OBJECTIVES: I. To determine in patients treated with the combination of binimetinib and encorafenib as >= 2nd line of treatment for patients with metastatic pancreatic cancer with BRAF V600E mutation: Ia. --- V600E ---



HPO Nodes


HPO: