Metastatic Colorectal CancerNCT04446793
Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Mutated Metastatic Colorectal Cancer
A study testing Onvansertib, Bevacizumab and FOLFIRI in people with Metastatic Colorectal Cancer and KRAS Gene Mutation, run by Cardiff Oncology.
Trial summary
This is an expanded access program for eligible participants designed to provide access to onvansertib in combination with FOLFIRI and bevacizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer, KRAS Gene Mutation
- What is being tested?
- Onvansertib, Bevacizumab and FOLFIRI
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
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)
This is an expanded access program for eligible participants designed to provide access to onvansertib in combination with FOLFIRI and bevacizumab.
- Conditions
- Metastatic Colorectal Cancer, KRAS Gene Mutation
- Being tested
- Onvansertib, Bevacizumab, FOLFIRI
- Keywords
- Colorectal Cancer, KRAS-Mutation, Onvansertib, PCM-075, FOLFIRI, Irinotecan, 5-Fluoruracil, Bevacizumab
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnvansertibDrug
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.
BevacizumabBiological
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.
FOLFIRIDrug
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cardiff Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446793
- Sponsor's protocol ID
- CRDF-01E
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2020
- Last updated
- 12 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04446793
- Acronym / sponsor ID
- CRDF-01E
- Conditions
- Metastatic Colorectal Cancer, KRAS Gene Mutation
- Keywords
- Colorectal Cancer, KRAS-Mutation, Onvansertib, PCM-075, FOLFIRI, Irinotecan, 5-Fluoruracil, Bevacizumab
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Cardiff OncologyIndustry (pharma, biotech, devices)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an expanded access program for eligible participants designed to provide access to onvansertib in combination with FOLFIRI and bevacizumab.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onvansertib15 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. | Drug | – |
| Bevacizumab5 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. | Biological | – |
| FOLFIRIFOLFIRI (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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Onvansertib, Bevacizumab and FOLFIRI in people with Metastatic Colorectal Cancer and KRAS Gene Mutation, run by Cardiff Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.