- Advanced colorectal carcinoma.
- Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC
or progression within 6 months of end of oxaliplatin-containing regimen in the
- Tumor tissue available at time of screening for molecular profiling.
- Adequate performance status.
- Adequate glucose control, bone marrow, kidney, liver, and heart function.
- Participation in other studies involving investigational drug(s) (Phases 1-4) before
the current study begins and/or during study participation.
- Prior irinotecan treatment.
- Prior radiation to the pelvis or abdomen in the metastatic or locally advanced
- History of Gilbert's syndrome.
- Active brain metastases.
- Deep vein thrombosis in the preceding 2 months.
- History of interstitial lung disease.
- RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing
regimen (unless contraindicated or not considered standard practice per clinical site
or country guidelines).