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A Study to Investigate Ompenaclid Combined With FOLFIRI Plus Bevacizumab in Advanced/Metastatic Colorectal Cancer
Phase 2
Waitlist Available
Research Sponsored by Inspirna, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization until death due to any cause (estimated up to 36 months).
Summary
The purpose of this study is to measure tumor response to treatment with ompenaclid (RGX-202-01) in patients with previously treated RAS mutant advanced or metastatic CRC. All patients will receive treatment with FOLFIRI and bevacizumab. In addition, patients will be randomized to receive either ompenaclid 3000 mg BID or matching placebo (herein referred to as Study Drug). Each treatment cycle is 28 days in duration.
Eligible Conditions
- Colorectal Cancer
- Colon Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization until death due to any cause (estimated up to 36 months).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization until death due to any cause (estimated up to 36 months).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DoR)
Exploratory biomarkers that may correlate with efficacy outcomes
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ompenaclid + FOLFIRI + BevacizumabExperimental Treatment3 Interventions
Ompenaclid (RGX-202-01) 3000mg PO (tablets) BID; Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
Group II: Placebo + FOLFIRI + BevacizumabPlacebo Group3 Interventions
Placebo (tablets) PO + Irinotecan: 180 mg/m2 over 90 minutes concurrently with folinic acid 400 mg/m2 over 2 hours, followed by 5-FU 2400 mg/m2 over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
FOLFIRI regimen
2021
Completed Phase 3
~1070
Find a Location
Who is running the clinical trial?
Inspirna, Inc.Lead Sponsor
2 Previous Clinical Trials
254 Total Patients Enrolled
Osamu Takahashi, MDStudy DirectorInspirna, Inc.
Robert Wasserman, MDStudy DirectorCMO
3 Previous Clinical Trials
295 Total Patients Enrolled