Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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This is an expanded access program for eligible participants designed to provide access to onvansertib in combination with FOLFIRI and bevacizumab.

Official Title
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An Expanded Access Program of Onvansertib in Combination With FOLFIRI and Bevacizumab for the Second-Line Treatment of Patients With KRAS-Mutated Metastatic Colorectal Cancer (mCRC)

Conditions
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Metastatic Colorectal Cancer, KRAS Gene Mutation

Intervention / Treatment
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* Drug: Onvansertib
* Biological: Bevacizumab
* Drug: FOLFIRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is NOT eligible for other clinical trials currently open in the region Participant has failed or progressed on standard of care systemic therapy FOLFIRI (with or without 5FU bolus and continuous infusion)/bevacizumab plus onvansertib is appropriate for the participant as determined by the treating physician, including participants who have previously been treated with FOLFIRI Histologically confirmed metastatic and unresectable CRC with a confirmed KRAS mutation Age ≥ 18 years Women of Child-bearing Potential Women of child-bearing potential (WOCBP) must agree to use method(s) of contraception WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the start of onvansertib treatment If sexually active, the participant must agree to use contraception considered adequate and appropriate by the treating physician during the period of onvansertib administration Exclusion Criteria: Participant has not recovered from minor or major surgery and less than 6 weeks out from major surgery Participant has active Hepatitis B or C infection Participant has a known history of testing positive for human immunodeficiency virus or having been diagnosed with acquired immunodeficiency syndrome Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure Class II or higher according to the New York Heart Association Functional Classification, unstable angina pectoris, significant pulmonary disease (shortness of breath at rest or mild exertion), that would limit compliance with study requirements Abnormal glucuronidation of bilirubin, known Gilbert's syndrome Participants with any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, altered mental status, or psychiatric condition that, in the opinion of the treating physician, would substantially increase risk to their well-being Any condition that, in the opinion of the treating physician, would substantially increase risk to their well-being

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Onvansertib|15 mg/m^2 will be administered orally on Day 1 to Day 5 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.|
|Biological: Bevacizumab|5 mg/kg will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.|
|Drug: FOLFIRI|FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil [5-FU], and 2400 mg/m^2 continuous intravenous infusion 5-FU over 46 hours) will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Cancer, KRAS-Mutation, Onvansertib, PCM-075, FOLFIRI, Irinotecan, 5-Fluoruracil, Bevacizumab