Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564938
• Other study ID #: 19214
• Status: Completed
• Phase: Phase 4
• Start date: July 30, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

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).

Locations

Country	Name	City	State
India	Healthcare Center Global Hospital	Ahmedabad	Gujarat
India	Sparsh Hospital & Critical Care	Bhubaneswar	Orissa
India	Apollo Research Foundation	Hyderabad	Andhra Pradesh
India	Shalby Hospital	Jaipur	Rajasthan
India	Health Point Hospital	Kolkata	West Bengal
India	IPGME & R / SSKM Hospital	Kolkata	West Bengal
India	Apollo Speciality Hospitals	Madurai	Tamil N?du
India	Jaslok Hospital and Research Centre	Mumbai	Maharashtra
India	Sushrut Hospital & Research Centre	Mumbai	Maharashtra
India	Tata Memorial Hospital	Mumbai	Maharashtra
India	Sir Ganga Ram Hospital	New-Delhi	Delhi
India	Jehangir Hospital	Pune	Maharashtra
India	Fortis Hospital	West-Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events		From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Primary	Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)		From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Primary	Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements		From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Primary	Change in Body weight (kg)		From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Primary	Change in Systolic / Diastolic BP (mmHg)		From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Primary	Change in heart rate (beats/min)		From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Secondary	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	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
Secondary	Overall response rate (ORR)	Defined as proportion of patients achieving CR, and PR per RECIST v.1.1	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
Secondary	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.	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
Secondary	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.	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

External Links

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