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Clinical Trials/CTRI/2018/06/014371
CTRI/2018/06/014371
Completed
Phase 4

A phase IV study to investigate the safety and efficacy of regorafenib in Indianpatients with metastatic colorectal cancer (mCRC) - CORA

Bayer AG0 sites100 target enrollmentTBD
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ConditionsHealth Condition 1: null- metastatic colorectal cancer mCRC

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- metastatic colorectal cancer mCRC
Sponsor
Bayer AG
Enrollment
100
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
September 10, 2023
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Bayer AG

Eligibility Criteria

Inclusion Criteria

  • •1Signed informed consent obtained before any study specific procedures. Patients must be able to understand and willing to sign a written informed consent
  • •2 Male or female patients (\>\=18 years of age) with metastatic (Stage IV) colorectal adenocarcinoma confirmed either histologically or cytologically with measurable metastatic disease according to RECIST v. 1\.1
  • •3 Patients must have PD after receiving the approved standard
  • •4 Patients must have ECOG PS of 0 or 1 and a life expectancy of atleast 3 months
  • •5 Adequate bone marrow, liver and renal function;
  • •6 Women of childbearing potential and men must agree to use adequate contraception.

Exclusion Criteria

  • •1 Unresolved toxicity greater than Grade 1 from prior treatment for
  • •2 Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)
  • •3 Subjects unable to swallow oral medications
  • •Any malabsorption condition;
  • •4 Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patientâ??s participation in the

Outcomes

Primary Outcomes

Not specified

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