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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

Primary Purpose

Metastatic Colorectal Cancer, KRAS Gene Mutation

Status

No longer available

Phase

Locations

Study Type

Expanded Access

Intervention

Onvansertib

Bevacizumab

FOLFIRI

About this trial

This is an expanded access trial for Metastatic Colorectal Cancer focused on measuring Colorectal Cancer, KRAS-Mutation, Onvansertib, PCM-075, FOLFIRI, Irinotecan, 5-Fluoruracil, Bevacizumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04446793

First Posted

June 22, 2020

Last Updated

January 18, 2021

Sponsor

Cardiff Oncology

1. Study Identification

Unique Protocol Identification Number

NCT04446793

Brief Title

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

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)

Study Type

Expanded Access

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

No longer available

Study Start Date

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Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cardiff Oncology

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Colorectal Cancer, KRAS Gene Mutation

Keywords

Colorectal Cancer, KRAS-Mutation, Onvansertib, PCM-075, FOLFIRI, Irinotecan, 5-Fluoruracil, Bevacizumab

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Onvansertib

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Bevacizumab

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

FOLFIRI

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

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

12. IPD Sharing Statement

Learn more about this trial

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

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