Status and phase
Conditions
Treatments
About
The primary objective of this study is to assess the efficacy of 2 different doses of onvansertib in combination with a chemotherapy regimen of irinotecan, fluorouracil [5-FU], and leucovorin (FOLFIRI) and bevacizumab for treatment of confirmed metastatic and/or unresectable colorectal cancer (CRC) in participants with a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation who have progressed on an oxaliplatin/fluoropyrimidinebased regimen in the first-line setting.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically confirmed metastatic and/or unresectable colorectal cancer (CRC).
Documentation of a kirsten rat sarcoma virus gene (KRAS) or neuroblastoma-RAS (NRAS) mutation in exon 2, 3, or 4 in primary tumor or metastasis, assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
Age ≥ 18 years.
Participants with tumors that have progressed on an oxaliplatin/fluoropyrimidine--based regimen with or without bevacizumab.
Participants must not have received prior treatment with irinotecan.
FOLFIRI therapy is appropriate for the participant as determined by the Investigator.
Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis or other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib. Only participants with measurable disease as defined per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) are eligible for enrollment. CT is the preferred imaging modality, but MRI is also accepted. All subsequent scans must consistently use the same imaging modality for comparison with the Screening scan throughout the study.
Must have acceptable organ function
Signed informed consent to provide blood sample(s) for specific correlative assays
Exclusion criteria
Concomitant KRAS or NRAS and BRAF-V600 mutation or Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/dMMR).
Anti-cancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug. The exception is a single dose of radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before enrollment, provided it is not the target lesion.
More than 1 prior chemotherapy regimen administered in the metastatic setting.
Major surgery within 6 weeks prior to enrollment.
Untreated or symptomatic brain metastasis.
Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (e.g., intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection).
Unable or unwilling to swallow study drug.
Known hypersensitivity to fluoropyrimidine or leucovorin.
Known hypersensitivity to irinotecan.
Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
QT interval:
Use of strong cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19) inhibitors or strong CYP3A4 inducers. Participants currently receiving these agents who can be switched to alternate therapy are not excluded. Inhibitors should be stopped at least 1 week prior to the first dose of protocol therapy and inducers should be stopped at least 2 weeks prior to initiation of protocol therapy.
The following are exclusion criteria for bevacizumab:
Primary purpose
Allocation
Interventional model
Masking
23 participants in 3 patient groups
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Central trial contact
Nancy Sherman
Data sourced from clinicaltrials.gov
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