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Trial record 1 of 1 for:    NCT03564938
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Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

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ClinicalTrials.gov Identifier: NCT03564938
Recruitment Status : Active, not recruiting
First Posted : June 21, 2018
Last Update Posted : March 14, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual 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 : April 7, 2023
Estimated Study Completion Date : October 6, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib ]
  2. 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 ]
  3. 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 ]
  4. Change in Body weight (kg) [ Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib ]
  5. Change in Systolic / Diastolic BP (mmHg) [ Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib ]
  6. Change in heart rate (beats/min) [ Time Frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib ]

Secondary Outcome Measures :
  1. 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

  2. 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 ]
    Defined as proportion of patients achieving CR, and PR per RECIST v.1.1

  3. 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.

  4. 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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


Locations
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India
Apollo Research Foundation
Hyderabad, Andhra Pradesh, India, 500096
Sir Ganga Ram Hospital
New-Delhi, Delhi, India, 110060
Healthcare Center Global Hospital
Ahmedabad, Gujarat, India, 380060
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Jaslok Hospital and Research Centre
Mumbai, Maharashtra, India, 400026
Sushrut Hospital & Research Centre
Mumbai, Maharashtra, India, 400071
Jehangir Hospital
Pune, Maharashtra, India, 411001
Fortis Hospital
West-Mumbai, Maharashtra, India, 400078
Sparsh Hospital & Critical Care
Bhubaneswar, Orissa, India, 751007
Shalby Hospital
Jaipur, Rajasthan, India, 302021
Apollo Speciality Hospitals
Madurai, Tamil N?du, India, 625020
IPGME & R / SSKM Hospital
Kolkata, West Bengal, India, 700020
Health Point Hospital
Kolkata, West Bengal, India, 700025
Sponsors and Collaborators
Bayer
More Information
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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: March 14, 2023
Last Verified: March 2023

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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