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

Sponsor

Cardiff Oncology (Industry)

Overall Status

No longer available

CT.gov ID

NCT04446793

Collaborator

(none)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer KRAS Gene Mutation	Drug: Onvansertib Biological: Bevacizumab Drug: FOLFIRI

Study Design

Study Type:

Expanded Access

Official Title:

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)

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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