Trial Condition(s):
Metastatic Colorectal Cancer
Regorafenib in Indian patients with metastatic colorectal cancer (mCRC).
Bayer Identifier:
19214
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Fortis Hospital West-Mumbai, India, 400078 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Health Point Hospital Kolkata, India, 700025 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tata Memorial Hospital Mumbai, India, 400012 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sir Ganga Ram Hospital New-Delhi, India, 110060 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations IPGME & R / SSKM Hospital Kolkata, India, 700020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Apollo Speciality Hospitals Madurai, India, 625020 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jaslok Hospital and Research Centre Mumbai, India, 400026 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Jehangir Hospital Pune, India, 411001 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Healthcare Center Global Hospital Ahmedabad, India, 380060 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sparsh Hospital & Critical Care Bhubaneswar, India, 751007 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shalby Hospital Jaipur, India, 302021 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Sushrut Hospital & Research Centre Mumbai, India, 400071 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Apollo Research Foundation Hyderabad, India, 500096 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A phase IV study to investigate the safety and efficacy of regorafenib in Indian patients with metastatic colorectal cancer (mCRC).
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Number of Adverse EventsTimeframe: 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)Timeframe: 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 measurementsTimeframe: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
- Change in Body weight (kg)Timeframe: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
- Change in Systolic / Diastolic BP (mmHg)Timeframe: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
- Change in heart rate (beats/min)Timeframe: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Secondary Outcome
- Disease control rate (DCR)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. 1.1Timeframe: 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 response rate (ORR)Defined as proportion of patients achieving CR, and PR per RECIST v.1.1Timeframe: 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)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.Timeframe: 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)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.Timeframe: 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
Additional Information
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