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

NCT ID: NCT03564938

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2023-12-01

Brief Summary

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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

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regorafenib (Stivarga, BAY 73-4506)

Patients with metastatic colorectal cancer

Group Type EXPERIMENTAL

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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Nublexa

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Apollo Research Foundation

Hyderabad, Andhra Pradesh, India

Site Status

Shalby Hospital

Ahmedabad, Gujarat, India

Site Status

Healthcare Center Global Hospital

Ahmedabad, Gujarat, India

Site Status

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status

Jaslok Hospital and Research Centre

Mumbai, Maharashtra, India

Site Status

Sushrut Hospital & Research Centre

Mumbai, Maharashtra, India

Site Status

Jehangir Hospital

Pune, Maharashtra, India

Site Status

Fortis Hospital

West-Mumbai, Maharashtra, India

Site Status

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status

Sparsh Hospital & Critical Care

Bhubaneswar, Odisha, India

Site Status

Apollo Speciality Hospitals

Madurai, Tamil Nadu, India

Site Status

IPGME & R / SSKM Hospital

Kolkata, West Bengal, India

Site Status

Health Point Hospital

Kolkata, West Bengal, India

Site Status

Countries

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India

Related Links

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https://clinicaltrials.bayer.com/study/19214

Click here to find further information and, after study completion, they study results according to Bayer's transparency standards.

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217261&parentIdentifier=19214&attachmentIdentifier=0bcd1efc-e45e-4f5d-bc72-fd89716bf3af&fileName=19214_Websynopsis_CTP.pdf&versionIdentifier=

Study\_Synopsis-19214.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (255.0), Protocol (38.2), Results(0.1)

Other Identifiers

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19214

Identifier Type: -

Identifier Source: org_study_id