A Phase Ib Study Combining Irinotecan With AZD1775 a Selective Wee 1 Inhibitor in RAS (KRAS or NRAS) or BRAF Mutated Metastatic Colorectal Cancer Patients Who Have Progressed on First Line Therapy

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Metastatic Colorectal Cancer (ras (kras Or Nras) Or Braf Mutated)
  • Age: Between 18 years - 120 years
  • Gender: Male or Female
  • Other Inclusion Criteria:

    1. Patients must have been diagnosed with stage IV colorectal cancer.

    2. Individuals relapsing within 12 months of completing adjuvant FOLFOX (folinic acid, Fluorouracil, Oxaliplatin) also eligible.

    3. Individuals with failure of first-line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or subsequent relapse of disease following first-line therapy are eligible.

    4. Tumor sample must be evaluated and have confirmed KRAS or NRAS [codons 12 and 13 (exon 2), 59 and 61 (exon 3), and 117 and 146 (exon 4)] or BRAF [codon 600 (exon 15)] mutation positive.


You may not be eligible for this study if the following are true:

  • 1.  Received more than 1 line of systemic treatment for advanced/metastatic CRC and/or a patient whose first line therapy did not contain oxaliplatin and bevacizumab

     

    2.  Prior treatment with a Wee1 inhibitor or any Irinotecan containing regimen

     

    3.  History of hypersensitivity to AZD1775, Irinotecan, or any compounds of these agents

     

    4.  Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroid and anti-convulsants for at least 3 months.




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