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

NCT04446793 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-02-12

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cardiff Oncology

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446793 on ClinicalTrials.gov