18 and older, any sex, with Metastatic Colorectal Cancer or KRAS Gene Mutation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)Primary· Up to Day 28
DLTs were defined as a Grade 4 hematologic adverse events (AEs), Grade ≥ 3 non-hematologic AEs that were considered related to the study drug and that did not resolve within 14 days following presentation with standard management and care, Grade ≥ 3 thrombocytopenia with bleeding, neutropenic fever, any death not clearly due to the underlying disease or extraneous causes, or any change in liver function that met Hy's Law criteria of a DLT.
Group
Value
95% CI
Phase 1b: Onvansertib 12 mg/m^2
1
Phase 1b: Onvansertib 15 mg/m^2
1
Phase 1b: Onvansertib 18 mg/m^2
3
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· Up to a maximum of 81 weeks
AEs were defined as any untoward medical occurrence associated with the use of a drug in humans. TEAEs are defined as any AE that started on or after the first day of study treatment and within 30 days of the last administration of study treatment, or that worsened on or after the first day of study treatment. AE severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 on a scale from Grade 1 (mild) to Grade 5 (death). An AE was considered "serious" if it resulted in death, life-threatening AE, hospitalization or prolonga
Any TEAE
Group
Value
95% CI
Phase 1b: Onvansertib 12 mg/m^2
9
Phase 1b: Onvansertib 15 mg/m^2
7
Phase 1b: Onvansertib 18 mg/m^2
6
Any TEAE Related to Onvansertib
Group
Value
95% CI
Phase 1b: Onvansertib 12 mg/m^2
8
Phase 1b: Onvansertib 15 mg/m^2
7
Phase 1b: Onvansertib 18 mg/m^2
4
Any TEAE CTCAE Grade ≥3
Group
Value
95% CI
Phase 1b: Onvansertib 12 mg/m^2
7
Phase 1b: Onvansertib 15 mg/m^2
6
Phase 1b: Onvansertib 18 mg/m^2
4
Any TEAE CTCAE Grade ≥3 Related to Onvansertib
Group
Value
95% CI
Phase 1b: Onvansertib 12 mg/m^2
4
Phase 1b: Onvansertib 15 mg/m^2
1
Phase 1b: Onvansertib 18 mg/m^2
1
Any Serious TEAE
Group
Value
95% CI
Phase 1b: Onvansertib 12 mg/m^2
2
Phase 1b: Onvansertib 15 mg/m^2
3
Phase 1b: Onvansertib 18 mg/m^2
1
Any Serious TEAE Related to Onvansertib
Group
Value
95% CI
Phase 1b: Onvansertib 12 mg/m^2
0
Phase 1b: Onvansertib 15 mg/m^2
0
Phase 1b: Onvansertib 18 mg/m^2
0
All-Treated Analysis Set: Objective Response Rate (ORR)Primary· Up to a maximum of 131 weeks
ORR was defined as the percentage of participants documented to have a confirmed complete response (CR) or partial response (PR) using the Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1). Two-sided 95% confidence interval (CI) was calculated using the exact binomial Clopper-Pearson method.
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis).
PR: at least a 30% decrease in the su
Group
Value
95% CI
Phase 1b: Onvansertib 15 mg/m^2
42.9
9.9 – 81.6
Phase 2 Part 1: Onvansertib 15 mg/m^2
27.3
13.3 – 45.5
Phase 2 Part 2: Onvansertib 15 mg/m^2
15.4
1.9 – 45.4
Phase 1b and 2 Total: Onvansertib 15 mg/m^2
26.4
15.3 – 40.3
Phase 2: Number of Participants With TEAEsSecondary· Up to a maximum of 131 weeks
AEs were defined as any untoward medical occurrence associated with the use of a drug in humans. TEAEs are defined as any AE that started on or after the first day of study treatment and within 30 days of the last administration of study treatment, or that worsened on or after the first day of study treatment. AE severity was graded according to the CTCAE version 5.0 on a scale from Grade 1 (mild) to Grade 5 (death). An AE was considered "serious" if it resulted in death, life-threatening AE, hospitalization or prolongation of hospitalization, persistent or significant incapacity, or congenita
Any TEAE
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
46
Any TEAE Related to Onvansertib
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
26
Any TEAE CTCAE Grade ≥3
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
32
Any TEAE CTCAE Grade ≥3 Related to Onvansertib
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
8
Any Serious TEAE
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
17
Any Serious TEAE Related to Onvansertib
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
1
All-Treated Analysis Set: Disease Control Rate (DCR)Secondary· Up to a maximum of 131 weeks
DCR was defined as the percentage of participants documented to have a confirmed CR, PR or stable disease (SD) using the RECIST v1.1. Two-sided 95% CI was calculated using the exact binomial Clopper-Pearson method.
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters.
SD: neither suff
Group
Value
95% CI
Phase 1b: Onvansertib 15 mg/m^2
100
59.0 – 100.0
Phase 2 Part 1: Onvansertib 15 mg/m^2
90.9
75.7 – 98.1
Phase 2 Part 2: Onvansertib 15 mg/m^2
92.3
64.0 – 99.8
Phase 1b and 2 Total: Onvansertib 15 mg/m^2
92.5
81.8 – 97.9
All-Treated Analysis Set: Progression-free Survival (PFS)Secondary· Up to a maximum of 131 weeks
PFS was defined as the time in months from the date of first administration of study treatment until the first observation of PD or death due to any cause, whichever occurs first, i.e.: (date of first PD or death date of first administration of study treatment +1)/30.4375. Median and 95% CI were calculated using the Kaplan-Meier method. Participants who did not have an observed documented PD or death from any cause were censored at the latest tumor response assessment date.
PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at l
Group
Value
95% CI
Phase 1b: Onvansertib 15 mg/m^2
18
3.7 – NA
Phase 2 Part 1: Onvansertib 15 mg/m^2
6
5.6 – 11.1
Phase 2 Part 2: Onvansertib 15 mg/m^2
8
3.9 – NA
Phase 1b and 2 Total: Onvansertib 15 mg/m^2
8
5.8 – 13.5
All-Treated Analysis Set: Duration of Response (DoR)Secondary· Up to a maximum of 131 weeks
DoR was calculated as the (date of first documented tumor progression or death due to any cause minus date of first documentation of a subsequently confirmed objective response plus 1)/30.4375. Participants who did not have an observed documented PD or death from any cause were censored at the latest tumor response assessment date.
Group
Value
95% CI
Phase 1b: Onvansertib 15 mg/m^2
12
NA – NA
Phase 2 Part 1: Onvansertib 15 mg/m^2
12
3.8 – NA
Phase 2 Part 2: Onvansertib 15 mg/m^2
NA
NA – NA
Phase 1b and 2 Total: Onvansertib 15 mg/m^2
12
7.5 – NA
All-Treated Analysis Set: Overall Survival (OS)Secondary· Up to a maximum of 131 weeks
OS was defined as the time in months from the date of first administration of study treatment until death due to any cause, i.e.: (Date of death date of first administration of study treatment +1)/30.4375. Participants who did not have documented death from any cause were censored at the date they were last known to be alive. OS was added as an endpoint with Protocol Amendment #1, therefore, OS data was only collected from then onward.
Group
Value
95% CI
Phase 1b: Onvansertib 15 mg/m^2
NA
NA – NA
Phase 2 Part 1: Onvansertib 15 mg/m^2
NA
19.7 – NA
Phase 2 Part 2: Onvansertib 15 mg/m^2
NA
14.4 – NA
Phase 1b and 2 Total: Onvansertib 15 mg/m^2
NA
19.7 – NA
All-Treated Analysis Set: Percentage Change in KRAS-mutant Allelic Fraction (MAF)Secondary· Cycle 1 Day 1 and Cycle 2 Day 1 (28-day cycle length)
Blood samples were analyzed for the presence of circulating tumor DNA (ctDNA \[including KRAS mutations\]). KRAS-mutant allelic burden was based on liquid biopsies.
Group
Value
95% CI
Phase 1b: Onvansertib 15 mg/m^2
-85.5857
± 19.44200
Phase 2 Part 1: Onvansertib 15 mg/m^2
-76.2323
± 26.43313
Phase 2 Part 2: Onvansertib 15 mg/m^2
-62.0000
± 33.72414
Phase 1b and 2 Total: Onvansertib 15 mg/m^2
-74.9000
± 27.45740
Phase 2: Observed Plasma Concentration at the End of Each Dosing Interval (Ctrough) of OnvansertibSecondary· Pre-dose on Day 1 of Cycles 1 and 3 (28-day cycle length)
Plasma pharmacokinetic (PK) parameters for onvansertib were estimated using non-compartmental methods.
Cycle 1 Day 1
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
0.0000
± 0.0000
Cycle 3 Day 1
Group
Value
95% CI
Phase 2: Onvansertib 15 mg/m^2
0.3406
± 0.34496
All-Treated Analysis Set: ORR by Bevacizumab Used in First-line TreatmentSecondary· Up to a maximum of 131 weeks
ORR was defined as the percentage of participants documented to have a confirmed CR or PR using the RECIST v1.1. Two-sided 95% CI was calculated using the exact binomial Clopper-Pearson method. Data are presented by bevacizumab used in first-line treatment yes versus no.
CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to \< 10 mm. All lymph nodes must have been non-pathological in size (\< 10mm short axis).
PR: at least a 30% decrease in the sum of diameters of target lesions, taking a
Group
Value
95% CI
Phase 1b; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
42.9
9.9 – 81.6
Phase 2 Part 1; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
4.5
0.1 – 22.8
Phase 2 Part 1; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2
72.7
39.0 – 94.0
Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
0
0.0 – 28.5
Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2
100
15.8 – 100.0
Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
10.0
2.8 – 23.7
Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2
76.9
46.2 – 95.0
All-Treated Analysis Set: PFS by Bevacizumab Used in First-line TreatmentSecondary· Up to a maximum of 131 weeks
PFS was defined as the time in months from the date of first administration of study treatment until the first observation of PD or death due to any cause, whichever occurs first, i.e.: (date of first PD or death date of first administration of study treatment +1)/30.4375. Median and 95% CI were calculated using the Kaplan-Meier method. Participants who did not have an observed documented PD or death from any cause were censored at the latest tumor response assessment date. Data are presented by bevacizumab used in first-line treatment yes versus no.
PD: at least a 20% increase in the sum of
Group
Value
95% CI
Phase 1b; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
18
3.7 – NA
Phase 2 Part 1; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
6
3.6 – 6.1
Phase 2 Part 1; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2
15
9.5 – NA
Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
8
3.7 – NA
Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2
NA
NA – NA
Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2
6
5.3 – 8.4
Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2
15
9.5 – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to a maximum of 131 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1b: Onvansertib 12 mg/m^2
Serious: 2/9 (22%)
Deaths: 0/9
Phase 1b: Onvansertib 15 mg/m^2
Serious: 3/7 (43%)
Deaths: 0/7
Phase 1b: Onvansertib 18 mg/m^2
Serious: 1/6 (17%)
Deaths: 0/6
Phase 2: Onvansertib 15 mg/m^2
Serious: 17/46 (37%)
Deaths: 1/46
Serious adverse events (33 terms)
Reaction
System
Phase 1b: Onvansertib 12 m…
Phase 1b: Onvansertib 15 m…
Phase 1b: Onvansertib 18 m…
Phase 2: Onvansertib 15 mg…
Vomiting
Gastrointestinal disorders
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
Nausea
Gastrointestinal disorders
—
—
—
—
Hepatectomy
Surgical and medical procedures
—
—
—
—
Hydronephrosis
Renal and urinary disorders
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
Diarrhoea
Gastrointestinal disorders
—
—
—
—
Colitis
Gastrointestinal disorders
—
—
—
—
Constipation
Gastrointestinal disorders
—
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
—
Large intestine perforation
Gastrointestinal disorders
—
—
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
—
Abdominal abscess
Infections and infestations
—
—
—
—
Hepatitis B
Infections and infestations
—
—
—
—
Liver abscess
Infections and infestations
—
—
—
—
Pyelonephritis
Infections and infestations
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
Subcutaneous abscess
Infections and infestations
—
—
—
—
Urosepsis
Infections and infestations
—
—
—
—
Sigmoidectomy
Surgical and medical procedures
—
—
—
—
Fatigue
General disorders
—
—
—
—
Systemic inflammatory response syndrome
General disorders
—
—
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
Retinal detachment
Eye disorders
—
—
—
—
Hepatic cirrhosis
Hepatobiliary disorders
—
—
—
—
Other adverse events (233 terms — click to expand)
The purpose of the Phase 1b/2 study is to determine the safety and efficacy of Onvansertib, administered orally, daily on Day 1-5 and Day 15-19 of each 28-day cycle, in combination with FOLFIRI + Bevacizumab, as second-line treatment in adult participants who have metastatic colorectal cancer with a KRAS mutation. Participants must have histologically confirmed metastatic and unresectable disease, and previously failed treatment or be intolerant to fluoropyrimidine and oxaliplatin with or without bevacizumab.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06398587 — Onvansertib in Combination With Gemcitabine and Nab-paclitaxel for the Treatment of Patients With Locally-advanced, Unre
· Phase 2
· withdrawn
NCT05549661 — Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome/MP
· Phase 1
· recruiting
NCT05593328 — Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatmen
· Phase 2
· completed
NCT05383196 — Onvansertib + Paclitaxel In TNBC
· Phase 1, PHASE2
· active not recruiting
NCT05450965 — Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer
· Phase 2
· recruiting
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· Phase 1
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· recruiting
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· Phase 2
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NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie
· recruiting
Other Cardiff Oncology trials
Trials by the same sponsor.
NCT05593328 — Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatmen
· Phase 2
· completed
NCT04752696 — Onvansertib in Combination With Nanoliposomal Irinotecan, Leucovorin, and Fluorouracil for Second-Line Treatment of Part
· Phase 2
· completed
NCT03414034 — Onvansertib in Combination With Abiraterone and Prednisone in Adult Patients With Metastatic Castration-Resistant Prosta
· Phase 2
· completed
NCT03303339 — Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (
· Phase 1, PHASE2
· completed
NCT04446793 — Expanded Access of Onvansertib With FOLFIRI and Bevacizumab for the Second-Line Treatment of Participants With KRAS-Muta
· no longer available
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cardiff Oncology
Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03829410.