A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
Overview
- Phase
- Phase 4
- Intervention
- Regorafenib (Stivarga, BAY73-4506)
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Bayer
- Enrollment
- 100
- Locations
- 13
- Primary Endpoint
- Number of Adverse Events
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a Phase IV, single-arm, prospective, open-label, multicenter, interventional study to evaluate safety and efficacy of regorafenib in patients with mCRC who have been previously treated with fluoropyrimidine , oxaliplatin-, and irinotecan based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Patients must have PD after receiving the approved standard therapies
- •Patients must have ECOG PS of 0 or 1 and a life expectancy of at least 3 months
- •Adequate bone marrow, liver and renal function
- •Women of childbearing potential and men must agree to use adequate contraception
Exclusion Criteria
- •Unresolved toxicity greater than Grade 1 from prior treatment for mCRC
- •Previous (within 28 days) or concomitant participation in another clinical study with investigational medicinal product(s)
- •Subjects unable to swallow oral medications
- •Any malabsorption condition
- •Any medical or surgical conditions within 28 days before start of regorafenib that will interfere with patient's participation in the study
Arms & Interventions
Regorafenib (Stivarga, BAY 73-4506)
Patients with metastatic colorectal cancer
Intervention: Regorafenib (Stivarga, BAY73-4506)
Outcomes
Primary Outcomes
Number of Adverse Events
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body weight (kg)
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body height (cm)
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Systolic / Diastolic BP (mmHg)
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in heart rate (beats/min)
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Secondary Outcomes
- Disease control rate (DCR)(In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first)
- Overall survival (OS)(In each participant, every 8 weeks from the start of regorafenib until death, lost to follow-up, consent withdrawn or end of study, whichever occurs first)
- Overall response rate (ORR)(In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first)
- Progression free survival (PFS)(In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first)