Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03564938|
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : May 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Regorafenib (Stivarga, BAY73-4506)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).|
|Actual Study Start Date :||July 30, 2018|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||April 20, 2022|
Experimental: Regorafenib (Stivarga, BAY 73-4506)
Patients with metastatic colorectal cancer
Drug: Regorafenib (Stivarga, BAY73-4506)
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 Name: Nublexa
- Number of Adverse Events [ Time Frame: Up to 30 days after the last dose of regorafenib ]
- Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Up to 30 days after the last dose of regorafenib ]
- Abnormal laboratory changes with clinical significance [ Time Frame: Up to 30 days after the last dose of regorafenib ]
- Changes in vital signs [ Time Frame: Up to 30 days after the last dose of regorafenib ]
- 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. 1.1 [ Time Frame: Up to 14 days post last dose or until radiologic progression ]
- Overall response rate (ORR) defined as proportion of patients achieving CR, and PR per RECIST v.1.1 [ Time Frame: Up to 14 days post last dose or until radiologic progression ]
- Progression free survival (PFS) [ Time Frame: Up to 28 months ]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.
- Overall survival (OS) [ Time Frame: Up to 28 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564938
|Contact: Bayer Clinical Trials Contact||(+) firstname.lastname@example.org|