- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03564938
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India, 500096
- Apollo Research Foundation
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Delhi
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New-Delhi, Delhi, India, 110060
- Sir Ganga Ram Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380060
- Healthcare Center Global Hospital
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Maharashtra
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Mumbai, Maharashtra, India, 400012
- Tata Memorial Hospital
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Mumbai, Maharashtra, India, 400026
- Jaslok Hospital and Research Centre
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Mumbai, Maharashtra, India, 400071
- Sushrut Hospital & Research Centre
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Pune, Maharashtra, India, 411001
- Jehangir Hospital
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West-Mumbai, Maharashtra, India, 400078
- Fortis Hospital
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Orissa
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Bhubaneswar, Orissa, India, 751007
- Sparsh Hospital & Critical Care
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Rajasthan
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Jaipur, Rajasthan, India, 302021
- Shalby Hospital
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Tamil N?du
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Madurai, Tamil N?du, India, 625020
- Apollo Speciality Hospitals
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West Bengal
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Kolkata, West Bengal, India, 700020
- IPGME & R / SSKM Hospital
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Kolkata, West Bengal, India, 700025
- Health Point Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Regorafenib (Stivarga, BAY 73-4506)
Patients with metastatic colorectal cancer
|
The recommended dose of regorafenib is 160 mg (consisting of 4 tablets, each containing 40 mg of regorafenib) for 3 weeks of every 4 week cycle, (ie. 3 weeks on therapy, 1 week off therapy).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Adverse Events
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
|
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
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From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
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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
|
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
|
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
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From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
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Change in heart rate (beats/min)
Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
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From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: 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
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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
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Overall response rate (ORR)
Time Frame: 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
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Defined as proportion of patients achieving CR, and PR per RECIST v.1.1
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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)
Time Frame: 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.
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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
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Overall survival (OS)
Time Frame: 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
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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.
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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
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19214 (Other Identifier: City of Hope Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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