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

Phase 4

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

• Registration Number: NCT03564938
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-24
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Study Start: 2018-07-30
• Primary Completion: 2023-03-20
• Study Completion: 2023-12-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regorafenib (Stivarga, BAY 73-4506)	Regorafenib (Stivarga, BAY73-4506)	Patients with metastatic colorectal cancer

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	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)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
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
Change in Body weight (kg)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body height (cm)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Systolic / Diastolic BP (mmHg)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in heart rate (beats/min)	From the start of regorafenib treatment up to 30 days after the last dose of regorafenib

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	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
Overall survival (OS)	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.
Overall response rate (ORR)	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
Progression free survival (PFS)	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.

Trial Locations

Locations (13)

Apollo Research Foundation; 🇮🇳 Hyderabad, Andhra Pradesh, India

Sir Ganga Ram Hospital; 🇮🇳 New-Delhi, Delhi, India

Shalby Hospital; 🇮🇳 Ahmedabad, Gujarat, India

Healthcare Center Global Hospital; 🇮🇳 Ahmedabad, Gujarat, India

Tata Memorial Hospital; 🇮🇳 Mumbai,, Maharashtra, India

Jaslok Hospital and Research Centre; 🇮🇳 Mumbai, Maharashtra, India

Sushrut Hospital & Research Centre; 🇮🇳 Mumbai, Maharashtra, India

Jehangir Hospital; 🇮🇳 Pune, Maharashtra, India

Fortis Hospital; 🇮🇳 West-Mumbai, Maharashtra, India

Sparsh Hospital & Critical Care; 🇮🇳 Bhubaneswar, Orissa, India

Apollo Speciality Hospitals; 🇮🇳 Madurai, Tamil Nadu, India

IPGME & R / SSKM Hospital; 🇮🇳 Kolkata, West Bengal, India

Health Point Hospital; 🇮🇳 Kolkata, West Bengal, India