Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This study is a Phase 1b/2, multi-center, open-label study in which patients with activating mutations in the RAS pathway (Phase 1b) and patients with NRAS-mutated Melanoma (Phase 2) will be treated with a combination of oral OKI-179 combined with the MEK inhibitor binimetinib.
Eligible Conditions
- Melanoma
- RAS Mutation
- NRAS Gene Mutation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 11 Secondary · Reporting Duration: Phase 1b study duration (approximately 1.5 years)
Day 30
Phase 1b: Change in clinical laboratory abnormalities
Day 28
Phase 1b: Area Under the Plasma Concentration vs. Time Curve (AUC) of OKI-179 and OKI-006
Phase 1b: Incidence and severity of dose-limiting toxicities (DLTs)
Phase 1b: Peak plasma concentration (Cmax) of OKI-179 and OKI-006
Phase 2: Area Under the Plasma Concentration vs. Time Curve (AUC) of OKI-179 and OKI-006
Phase 2: Peak plasma concentration (Cmax) of OKI-179 and OKI-006
Year 5
Phase 1b: Change in Eastern Cooperative Oncology Group (ECOG) performance status
Phase 1b: Clinical Benefit Rate (CBR)
Phase 1b: Duration of Response (DOR)
Phase 1b: Incidence and severity of adverse events (AEs)
Phase 1b: Objective response rate (ORR)
Year 3
Phase 2: Clinical Benefit Rate
Phase 2: Duration of Response
Phase 2: Incidence and severity of AEs
Phase 2: Objective response rate (ORR)
Phase 2: Progression-free survival (PFS)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
OKI-179 + binimetinib
1 of 1
Experimental Treatment
73 Total Participants · 1 Treatment Group
Primary Treatment: OKI-179 + binimetinib · No Placebo Group · Phase 1 & 2
OKI-179 + binimetinib
Drug
Experimental Group · 1 Intervention: OKI-179 + binimetinib · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: phase 1b study duration (approximately 1.5 years)
Closest Location: CTCA Southeastern Regional Medical Center · Newnan, GA
N/AFirst Recorded Clinical Trial
1 TrialsResearching Melanoma
0 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have at least 1 measurable lesion based on RECIST version 1.1.
You have a tumor with an activating mutation in the RAS pathway.
You have histologically confirmed, metastatic melanoma with a confirmed NRAS mutation.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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