A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)
Sponsor: AstraZeneca + Parexel
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression Free Survival (PFS)
Time frame: Approximately 3 years
Number of Participants with Adverse Events (AEs)
Time frame: Approximately 3 years
Secondary Endpoints
Overall Survival (OS)
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Eligibility Criteria
Overall Inclusion Criteria: * Histopathologically confirmed colorectal adenocarcinoma. * Provision of FFPE tumor sample collected as per SoC. * Presence of measurable disease by RECIST 1.1 criteria. * ECOG performance status of 0 or 1. * Life expectancy ≥ 12 weeks at the time of screening. Substudy Inclusion Criteria: * No radiological evidence of liver metastasis. * No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, \> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease. * Known pMMR/MSS status (only pMMR/MSS mCRC allowed). * Adequate organ and bone marrow function * Body weight \> 35 kg at screening and at randomization. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Overall Exclusion Criteria: * Central nervous system metastases or spinal cord compression * Kn…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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