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Chemotherapy
Onvansertib + FOLFIRI + Bevacizumab for Colorectal Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by Cardiff Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 28 days after last dose of study drug (up to 30 months)
Awards & highlights
Summary
This trial tests a new oral drug, Onvansertib, combined with standard chemotherapy and Bevacizumab, for adults with advanced colorectal cancer that has a Kras mutation. The treatment aims to stop cancer cells from multiplying and to starve the tumor by preventing it from getting nutrients. Bevacizumab is a standard first-line treatment in metastatic colorectal cancer, often combined with chemotherapy, and works by inhibiting the growth of blood vessels that supply the tumor.
Eligible Conditions
- Metastatic Colorectal Cancer
- KRAS Mutation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 28 days after last dose of study drug (up to 30 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 28 days after last dose of study drug (up to 30 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: Number of Participants With Adverse Events (AEs)
Phase 1: Number of Participants With Change from Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status
Phase 2: Number of Participants with an Objective Response Rate (ORR)
Secondary study objectives
Phase 2: Disease Control Rate (DCR)
Phase 2: Duration of Response (DoR)
Phase 2: Number of Participants with Progression-free Survival (PFS)
+1 moreSide effects data
From 2021 Phase 1 & 2 trial • 72 Patients • NCT0330333938%
Febrile neutropenia
31%
Hypokalaemia
28%
Diarrhoea
28%
Stomatitis
25%
Fatigue
22%
Nausea
22%
Epistaxis
19%
Oedema peripheral
19%
Platelet count decreased
19%
Alopecia
16%
Hypophosphataemia
16%
Acute myeloid leukaemia
16%
Sepsis
16%
Dyspnoea
16%
Cough
16%
Hypoalbuminaemia
13%
Hypoxia
13%
Lung infection
13%
Anaemia
13%
Rash maculo-papular
13%
Rash
13%
Hypocalcaemia
13%
Arthralgia
13%
Hypertension
13%
Hypotension
9%
Syncope
9%
Electrocardiogram QT prolonged
9%
Pneumonia
9%
Cellulitis
9%
Headache
9%
Abdominal pain upper
9%
Oral pain
9%
Staphylococcal infection
9%
Urinary tract infection
9%
Hypomagnesaemia
9%
Dizziness
9%
Oropharyngeal pain
9%
Petechiae
9%
Decreased appetite
9%
Alanine aminotransferase increased
9%
Abdominal pain
9%
Escherichia bacteraemia
9%
Blood creatine increased
9%
Mucosal inflammation
9%
Hyperbilirubinaemia
9%
Pleural effusion
9%
Vomiting
6%
Lower gastrointestinal haemorrhage
6%
Dry mouth
6%
Fluid overload
6%
Ear pain
6%
Dry skin
6%
Oral candidiasis
6%
Neuropathy peripheral
6%
Fall
6%
Pyrexia
6%
Nasal congestion
6%
Ecchymosis
6%
Blood alkaline phosphatase
6%
Insomnia
6%
Pain in extremity
6%
Haematemesis
6%
Odynophagia
6%
Proctalgia
6%
Staphylococcal bacteraemia
6%
Bacteraemia
6%
Pneumonia fungal
6%
Pruritus
6%
Dermatitis contact
6%
Purpora
6%
Non-cardiac chest pain
6%
Hyperkalaemia
6%
Hypercalcaemia
6%
Flank pain
6%
Aspartate aminotransferase increased
6%
Neutrophil count decreased
6%
Blood bilirubin increased
6%
Pleuritic pain
6%
Haematoma
6%
Conjunctival haemorrhage
3%
Tumour lysis syndrome
3%
Atrial fibrillation
3%
Mallory-Weiss syndrome
3%
Hyperglycaemia
3%
Myalgia
3%
Back pain
3%
Upper gastrointestinal haemorrhage
3%
Pain
3%
Respiratory failure
3%
Rash pruritic
3%
Musculoskeletal pain
3%
Face oedema
3%
Hyponatraemia
3%
Contusion
3%
Septic shock
3%
Candida infection
3%
Granulicatella bacteraemia
3%
Kidney infection
3%
Pancytopenia
3%
Colitis
3%
Melaena
3%
Constipation
3%
Transfusion reaction
3%
Dysgeusia
3%
Dyspnoea exertional
3%
Wheezing
3%
Neutropenia
3%
Weight decreased
3%
Anxiety
3%
Eye pruritus
3%
White blood cell count decreased
3%
Neutropenic colitis
3%
Mental status changes
3%
Chills
3%
Sinus tachycardia
3%
Haemoptysis
3%
Aphasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: Onvansertib 60 mg/m^2 + Decitabine
Phase 1b: Onvansertib 90 mg/m^2 + Decitabine
Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 12 mg/m^2 + Decitabine
Phase 1b: Onvansertib 40 mg/m^2 + Decitabine
Phase 1b: Onvansertib 60 mg/m^2 + Decitabine
Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine
Phase 1b: Onvansertib 18 mg/m^2 + Decitabine
Phase 1b: Onvansertib 27 mg/m^2 + Decitabine
Trial Design
1Treatment groups
Experimental Treatment
Group I: Onvansertib + FOLFIRI + BevacizumabExperimental Treatment3 Interventions
Phase 1b: Onvansertib escalating starting dose of 12 mg/m\^2 orally Day 1 through Day 5 and Day 15 through Day 19 of each 28-day cycle in combination with 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 + 5 mg/kg bevacizumab. This Phase 1b portion of the study has been completed.
Phase 2: Onvansertib Recommended Phase 2 Dose (RP2D) of 15 mg/m\^2 orally Day 1 through Day 5 and Day 15 through Day 19 of every 28-day cycle in combination with 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 + 5 mg/kg bevacizumab, with treatment modifications or delays based on unresolved toxicity experienced during a previous cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onvansertib
2017
Completed Phase 2
~220
FOLFIRI
2005
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5540
Find a Location
Who is running the clinical trial?
Cardiff OncologyLead Sponsor
10 Previous Clinical Trials
561 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years old or older.You have agreed to participate in the study and have signed a document saying so.You are not currently receiving any other cancer treatments except for non-interventional surveys or observational studies.You have had cancer in the past, except for certain types.You have a medical condition that could make it unsafe for you to take the study drug, or that could make it difficult for you to receive treatment.Your organs must be functioning properly.You have an ongoing illness that is not being properly managed.You have a noticeable buildup of fluid in your abdomen or lungs.You have already received and did not respond well to the chemotherapy drugs fluoropyrimidine and oxaliplatin, with or without bevacizumab, or you experienced side effects that made it hard to continue the treatment.You cannot or do not want to swallow the study medication.You have advanced colorectal cancer that cannot be removed by surgery.You have a specific mutation in your Kras gene that has been confirmed by a certified laboratory. If you have a mutation in both Kras and BRAF-V600 genes or Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/ddMMR), you cannot participate in this study.Your tumor tissue must be available for testing. If there is no existing sample, you will need to have a biopsy taken during screening.You should be able to perform your daily activities without much difficulty.You have received treatment for your cancer within the past 6 months, but you cannot have any treatment for 4 weeks before starting this study.You must have received chemotherapy treatment that includes a drug called oxaliplatin, with or without bevacizumab, for at least 6 weeks. If you received maintenance therapy with fluoropyrimidines, you may still be eligible with or without re-challenge with oxaliplatin in combination with fluoropyrimidines.If you have rectal cancer, receiving both pre-treatment and post-treatment will be considered as one treatment for advanced cancer.If you had to stop your first treatment because of side effects, you can still participate as long as your disease got worse less than 6 months after stopping that treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Onvansertib + FOLFIRI + Bevacizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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