NL-OMON55423
Completed
Not Applicable
An Open-label Phase 1 Study to Evaluate Drug-Drug Interactions of Agents Co-Administered with Encorafenib and Binimetinib in Patients with BRAF V600-mutant Unresectable or Metastatic Melanoma or Other Advanced Solid Tumors - Array 818-103
Array BioPharma Inc. (a wholly ownd subsidairy of Pfizer Inc.)0 sites10 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Array BioPharma Inc. (a wholly ownd subsidairy of Pfizer Inc.)
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed written informed consent;
- •2\. Male or female patient, age \>\= 18 years;
- •3\. Histologically confirmed diagnosis of locally advanced, unresectable or
- •metastatic cutaneous melanoma or unknown primary melanoma American Joint
- •Committee on Cancer (AJCC) Stage IIIB, IIIC or IV; or other BRAF V600\-mutant
- •advanced solid tumors;
- •4\. Presence of BRAF V600E and/or V600K mutation in tumor tissue prior to
- •enrollment, as determined using a local test;
- •5\. Evidence of measurable or non\-measurable lesions as detected by radiological
- •or photographic methods according to guidelines based onResponse Evaluation
Exclusion Criteria
- •1\. Symptomatic brain metastasis. Patients previously treated or untreated for
- •these conditions who are asymptomatic in the absence of corticosteroid and
- •anti\-epileptic therapy are allowed. ;
- •2\. History of reaction to any of the study medications in the arm the patient
- •is enrolled in this trial;
- •3\. Use, within 2 weeks prior to the start of encorafenib/binimetinib treatment
- •on Day 1 and through DDI phase (Day 28\), of any herbal medications/supplements
- •or any medications or foods that are moderate or strong inhibitors or inducers
- •of CYP3A4/5;
- •4\. Consumption of grapefruit, pomegranates, star fruits, Seville oranges or
Outcomes
Primary Outcomes
Not specified
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