Trial Outcomes & Findings for Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation (NCT NCT03829410)

Last Updated: 2025-03-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

68 participants

Primary outcome timeframe

Up to Day 28

Results posted on

2025-03-04

Participant Flow

The study enrolled a total of 68 participants from 7 investigative sites in the United States between June 2019 and January 2024.

Participant milestones

Participant milestones
Measure	Phase 1b: Onvansertib 12 mg/m^2 Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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.	Phase 1b: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2: Onvansertib 15 mg/m^2 Oral onvansertib recommended phase 2 dose (RP2D) of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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.
Overall Study STARTED	6	8	6	48
Overall Study COMPLETED	0	0	0	1
Overall Study NOT COMPLETED	6	8	6	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Onvansertib 12 mg/m^2 Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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.	Phase 1b: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2: Onvansertib 15 mg/m^2 Oral onvansertib recommended phase 2 dose (RP2D) of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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.
Overall Study Adverse Event	1	0	1	4
Overall Study Physician Decision	0	0	0	2
Overall Study Disease Progressing	3	4	2	31
Overall Study Miscellaneous	2	4	3	10

Baseline Characteristics

Onvansertib in Combination With FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer Patients With a KRAS Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=9 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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.	Phase 1b: Onvansertib 15 mg/m^2 n=7 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=6 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2: Onvansertib 15 mg/m^2 n=46 Participants Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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.	Total n=68 Participants Total of all reporting groups
Age, Continuous	60.3 years STANDARD_DEVIATION 10.75 • n=5 Participants	59.0 years STANDARD_DEVIATION 14.39 • n=7 Participants	57.5 years STANDARD_DEVIATION 16.93 • n=5 Participants	55.0 years STANDARD_DEVIATION 9.82 • n=4 Participants	56.3 years STANDARD_DEVIATION 11.08 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	19 Participants n=4 Participants	31 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	27 Participants n=4 Participants	37 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	39 Participants n=4 Participants	59 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	38 Participants n=4 Participants	54 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Body Surface Area	1.99 m^2 STANDARD_DEVIATION 0.315 • n=5 Participants	1.82 m^2 STANDARD_DEVIATION 0.293 • n=7 Participants	2.02 m^2 STANDARD_DEVIATION 0.316 • n=5 Participants	1.97 m^2 STANDARD_DEVIATION 0.264 • n=4 Participants	1.96 m^2 STANDARD_DEVIATION 0.277 • n=21 Participants

PRIMARY outcome

Timeframe: Up to Day 28

Population: Safety Analysis Set: defined as participants who received at least one dose of onvansertib in any cycle. Three participants enrolled in 15 mg/m\^2 (2 in Phase 2 and 1 in Phase 1b) were inadvertently dosed at 12 mg/m\^2 and are represented under Phase 1b 12 mg/m\^2, as pre-specified in SAP section 9.4.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=9 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=7 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=6 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs)	1 Participants	1 Participants	3 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 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 prolongation of hospitalization, persistent or significant incapacity, or congenital anomaly/birth defect. The Investigator determined relatedness to the use of onvansertib. Clinically significant changes in vital signs, laboratory parameters, electrocardiograms, physical examinations, weight, and Eastern Cooperative Oncology Group (ECOG) performance status were reported as AEs.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=9 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=7 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=6 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any Serious TEAE Related to Onvansertib	0 Participants	0 Participants	0 Participants	—	—	—	—	—
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE Related to Onvansertib	8 Participants	7 Participants	4 Participants	—	—	—	—	—
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE CTCAE Grade ≥3	7 Participants	6 Participants	4 Participants	—	—	—	—	—
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE	9 Participants	7 Participants	6 Participants	—	—	—	—	—
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAE CTCAE Grade ≥3 Related to Onvansertib	4 Participants	1 Participants	1 Participants	—	—	—	—	—
Phase 1b: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any Serious TEAE	2 Participants	3 Participants	1 Participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Up to a maximum of 131 weeks

Population: All-Treated Analysis Set: defined as participants who received at least 1 dose of assigned onvansertib in Cycle 1. Inclusive of the group of participants who were enrolled at 15 mg/m\^2 in Phase 1b and Phase 2 (Part 1 and Part 2) as pre-specified in SAP section 9.4.2.

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 sum of diameters of target lesions, taking as reference the Baseline sum diameters.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=33 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=13 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=53 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: Objective Response Rate (ORR)	42.9 percentage of participants Interval 9.9 to 81.6	27.3 percentage of participants Interval 13.3 to 45.5	15.4 percentage of participants Interval 1.9 to 45.4	26.4 percentage of participants Interval 15.3 to 40.3	—	—	—	—

SECONDARY outcome

Timeframe: Up to a maximum of 131 weeks

Population: Safety Analysis Set: defined as participants who received at least one dose of onvansertib in any cycle. Two participants from Phase 2 15 mg/m\^2 were inadvertently dosed at 12 mg/m\^2 dose level, as pre-specified in SAP section 9.4.

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 congenital anomaly/birth defect. The Investigator determined relatedness to the use of onvansertib. Clinically significant changes in vital signs, laboratory parameters, electrocardiograms, physical examinations, weight, and ECOG performance status were reported as AEs.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=46 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
Phase 2: Number of Participants With TEAEs Any TEAE Related to Onvansertib	26 Participants	—	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs Any TEAE CTCAE Grade ≥3	32 Participants	—	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs Any TEAE CTCAE Grade ≥3 Related to Onvansertib	8 Participants	—	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs Any Serious TEAE	17 Participants	—	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs Any Serious TEAE Related to Onvansertib	1 Participants	—	—	—	—	—	—	—
Phase 2: Number of Participants With TEAEs Any TEAE	46 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 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 sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=33 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=13 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=53 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: Disease Control Rate (DCR)	100 percentage of participants Interval 59.0 to 100.0	90.9 percentage of participants Interval 75.7 to 98.1	92.3 percentage of participants Interval 64.0 to 99.8	92.5 percentage of participants Interval 81.8 to 97.9	—	—	—	—

SECONDARY outcome

Timeframe: 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 least 5mm. Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=33 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=13 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=53 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: Progression-free Survival (PFS)	18 months Interval 3.7 to Upper CI was not calculable due to insufficient event data occurring above the median.	6 months Interval 5.6 to 11.1	8 months Interval 3.9 to Upper CI was not calculable due to insufficient event data occurring above the median.	8 months Interval 5.8 to 13.5	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=33 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=13 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=53 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: Duration of Response (DoR)	12 months CIs were not calculable due to censoring and insufficient event data occurring near the median.	12 months Interval 3.8 to Upper CI was not calculable due to insufficient event data occurring above the median.	NA months Median and CIs were not calculable as all participants were censored.	12 months Interval 7.5 to Upper CI was not calculable due to insufficient event data occurring above the median.	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=33 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=13 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=53 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: Overall Survival (OS)	NA months Median and CIs were not calculable as all participants were censored.	NA months Interval 19.7 to Median and upper CI were not calculable due to fewer than 50% events.	NA months Interval 14.4 to Median and upper CI were not calculable due to fewer than 50% events.	NA months Interval 19.7 to Median and upper CI were not calculable due to fewer than 50% events.	—	—	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 n=31 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=9 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=47 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: Percentage Change in KRAS-mutant Allelic Fraction (MAF)	-85.5857 percentage change in MAF Standard Deviation 19.44200	-76.2323 percentage change in MAF Standard Deviation 26.43313	-62.0000 percentage change in MAF Standard Deviation 33.72414	-74.9000 percentage change in MAF Standard Deviation 27.45740	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1 and 3 (28-day cycle length)

Population: PK Analysis Set: defined as all participants in the safety analysis set who had at least one evaluable plasma concentration of onvansertib.

Plasma pharmacokinetic (PK) parameters for onvansertib were estimated using non-compartmental methods.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=10 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
Phase 2: Observed Plasma Concentration at the End of Each Dosing Interval (Ctrough) of Onvansertib Cycle 1 Day 1	0.0000 ng/mL Standard Deviation 0.0000	—	—	—	—	—	—	—
Phase 2: Observed Plasma Concentration at the End of Each Dosing Interval (Ctrough) of Onvansertib Cycle 3 Day 1	0.3406 ng/mL Standard Deviation 0.34496	—	—	—	—	—	—	—

POST_HOC outcome

Timeframe: 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 as reference the Baseline sum diameters.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=22 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=11 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 n=11 Participants Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 n=2 Participants Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 n=40 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 n=13 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: ORR by Bevacizumab Used in First-line Treatment	42.9 percentage of participants Interval 9.9 to 81.6	—	4.5 percentage of participants Interval 0.1 to 22.8	72.7 percentage of participants Interval 39.0 to 94.0	0 percentage of participants Interval 0.0 to 28.5	100 percentage of participants Interval 15.8 to 100.0	10.0 percentage of participants Interval 2.8 to 23.7	76.9 percentage of participants Interval 46.2 to 95.0

POST_HOC outcome

Timeframe: 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 diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 12 mg/m^2 n=7 Participants Oral onvansertib 12 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 15 mg/m^2 Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b: Onvansertib 18 mg/m^2 n=22 Participants Oral onvansertib 18 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total: Onvansertib 15 mg/m^2 n=11 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 2 Part 2; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 n=11 Participants Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 2 Part 2; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 n=2 Participants Oral onvansertib RP2D of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-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. Participants enrolled in Phase 2 after protocol v2 were categorized under Part 2 due to change in the Inclusion/Exclusion criteria.	Phase 1b and 2 Total; Bevacizumab Used in First-line Treatment: Onvansertib 15 mg/m^2 n=40 Participants Oral onvansertib of 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.	Phase 1b and 2 Total; Bevacizumab Not Used in First-line Treatment: Onvansertib 15 mg/m^2 n=13 Participants Oral onvansertib 15 mg/m\^2 received on Days 1 through 5 and Days 15 through 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-FU, and 2400 mg/m\^2 continuous intravenous infusion 5-FU + 5 mg/kg bevacizumab.
All-Treated Analysis Set: PFS by Bevacizumab Used in First-line Treatment	18 percentage of participants Interval 3.7 to Upper CI was not calculable due to insufficient event data occurring above the median.	—	6 percentage of participants Interval 3.6 to 6.1	15 percentage of participants Interval 9.5 to Upper CI was not calculable due to insufficient event data occurring above the median.	8 percentage of participants Interval 3.7 to Upper CI was not calculable due to insufficient event data occurring above the median.	NA percentage of participants Median and CIs were not calculable as all participants were censored.	6 percentage of participants Interval 5.3 to 8.4	15 percentage of participants Interval 9.5 to Upper CI was not calculable due to insufficient event data occurring above the median.

Adverse Events

Phase 1b: Onvansertib 12 mg/m^2

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Phase 1b: Onvansertib 15 mg/m^2

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Phase 1b: Onvansertib 18 mg/m^2

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 2: Onvansertib 15 mg/m^2

Serious events: 17 serious events

Other events: 46 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Nancy Sherman, Head of Clinical Operations

Cardiff Oncology

Phone: 858-952-7570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place