A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab Versus FOLFIRI and Bevacizumab for Second Line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation
This investigational study will have subjects treated with FOLFIRI and bevacizumab alone (control arm) or with onvansertib in combination with FOLFIRI and bevacizumab (investigational arm).
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.
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1. Histologically confirmed metastatic and/or unresectable colorectal cancer (CRC);
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2. 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
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Amendments (CLIA)-certified laboratory;
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3. Age = 18 years;
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4. Participants with tumors that have progressed on an oxaliplatin/fluoropyrimidine--based regimen with or without bevacizumab;
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5. Participants must not have received prior treatment with irinotecan.
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1. Concomitant KRAS or NRAS and BRAF-V600 mutation or Microsatellite Instability High/Deficient Mismatch Repair (MSI-H/dMMR);
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2. 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
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pain control up to 14 days before enrollment, provided it is not the target lesion;
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3. More than 1 prior chemotherapy regimen administered in the metastatic setting;
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4. Major surgery within 6 weeks prior to enrollment;
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5. Untreated or symptomatic brain metastasis.
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