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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Cardiff Oncology
Study ID
NCT03829410
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • KRAS Gene Mutation
  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Onvansertib — DRUG
    Onvansertib orally.
  • Bevacizumab — BIOLOGICAL
    Bevacizumab intravenously.
  • FOLFIRI — DRUG
    FOLFIRI intravenously.

Study Details

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.

Key Dates

Start date
Jun 24, 2019
Status verified
Feb 2025
Primary completion
Jan 29, 2024
Completion
Jan 29, 2024

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Onvansertib + FOLFIRI + Bevacizumab
    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.

Primary Outcome Measure

Phase 1b: Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Up to Day 28 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic Cancer CenterPhoenixArizona85054-
CARTI Cancer CenterLittle RockArkansas72205-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Mayo Clinic FloridaJacksonvilleFlorida32224-
University of Kansas Medical Center Research InstituteKansas CityKansas66160-
Mayo Clinic RochesterRochesterMinnesota55905-
Inova Schar Cancer InstituteFairfaxVirginia22031-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Cancer Center· Phoenix, AZCARTI Cancer Center· Little Rock, ARUSC Norris Comprehensive Cancer Center· Los Angeles, CAMayo Clinic Florida· Jacksonville, FLUniversity of Kansas Medical Center Research Institute· Kansas City, KSMayo Clinic Rochester· Rochester, MN

Related Studies