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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 : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Regorafenib (Stivarga, BAY73-4506) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: Up to 30 days after the last dose of regorafenib ]
  2. Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) [ Time Frame: Up to 30 days after the last dose of regorafenib ]
  3. Abnormal laboratory changes with clinical significance [ Time Frame: Up to 30 days after the last dose of regorafenib ]
  4. Changes in vital signs [ Time Frame: Up to 30 days after the last dose of regorafenib ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com

Locations
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Sponsors and Collaborators
Bayer
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03564938    
Other Study ID Numbers: 19214
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
mCRC
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases