Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT03564938
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Regorafenib (Stivarga, BAY 73-4506) Regorafenib (Stivarga, BAY73-4506) Patients with metastatic colorectal cancer
- Primary Outcome Measures
Name Time Method Number of Adverse Events 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) 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 From the start of regorafenib treatment up to 30 days after the last dose of regorafenib Change in Body weight (kg) From the start of regorafenib treatment up to 30 days after the last dose of regorafenib Change in Body height (cm) From the start of regorafenib treatment up to 30 days after the last dose of regorafenib Change in Systolic / Diastolic BP (mmHg) From the start of regorafenib treatment up to 30 days after the last dose of regorafenib Change in heart rate (beats/min) From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
- Secondary Outcome Measures
Name Time Method 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 Defined as proportion of patients achieving complete response (CR), partial response (PR), or SD (stable disease) per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
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 survival is defined as the time from study drug assignment to death from any cause or last date when the patient was known to be alive.
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 Defined as proportion of patients achieving CR, and PR per RECIST v.1.1
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 Progression free survival is defined as the time from study drug assignment to progressive disease (PD) or death from any cause or date of last tumor assessment if the patient did not progress or die.
Trial Locations
- Locations (13)
Apollo Research Foundation
🇮🇳Hyderabad, Andhra Pradesh, India
Sir Ganga Ram Hospital
🇮🇳New-Delhi, Delhi, India
Shalby Hospital
🇮🇳Ahmedabad, Gujarat, India
Healthcare Center Global Hospital
🇮🇳Ahmedabad, Gujarat, India
Tata Memorial Hospital
🇮🇳Mumbai,, Maharashtra, India
Jaslok Hospital and Research Centre
🇮🇳Mumbai, Maharashtra, India
Sushrut Hospital & Research Centre
🇮🇳Mumbai, Maharashtra, India
Jehangir Hospital
🇮🇳Pune, Maharashtra, India
Fortis Hospital
🇮🇳West-Mumbai, Maharashtra, India
Sparsh Hospital & Critical Care
🇮🇳Bhubaneswar, Orissa, India
Apollo Speciality Hospitals
🇮🇳Madurai, Tamil Nadu, India
IPGME & R / SSKM Hospital
🇮🇳Kolkata, West Bengal, India
Health Point Hospital
🇮🇳Kolkata, West Bengal, India