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

February 9, 2024 updated by: Cardiff Oncology

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)

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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
  • Participant was previously enrolled in an existing Cardiff clinical trial that is ending and based on investigator judgement has responded to treatment using onvansertib plus FOLFIRI (with or without 5FU bolus) + bevacizumab

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRDF-01E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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