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NCT03564938CompletedPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 3 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
100 (actual)
First submitted
24 May 2018
Start date
30 Jul 2018
Primary completion date
20 Mar 2023
Lead sponsor
Bayer
NCT number
NCT03564938

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 100
  • From 30 Jul 2018 to the primary completion date, 20 Mar 2023
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 medical or surgical conditions within 28 days before start of regorafenib that will interfere with patient's participation in the study

Other illness

  • Any malabsorption condition

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Healthcare Center Global Hospital
Coordinator of this site? Confirm its status
AhmedabadIndiaUnknown status
Shalby Hospital
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AhmedabadIndiaUnknown status
Sparsh Hospital & Critical Care
Coordinator of this site? Confirm its status
BhubaneswarIndiaUnknown status
Apollo Research Foundation
Coordinator of this site? Confirm its status
HyderabadIndiaUnknown status
Health Point Hospital
Coordinator of this site? Confirm its status
KolkataIndiaUnknown status
IPGME & R / SSKM Hospital
Coordinator of this site? Confirm its status
KolkataIndiaUnknown status
Apollo Speciality Hospitals
Coordinator of this site? Confirm its status
MaduraiIndiaUnknown status
Sushrut Hospital & Research Centre
Coordinator of this site? Confirm its status
MumbaiIndiaUnknown status
Tata Memorial Hospital
Coordinator of this site? Confirm its status
MumbaiIndiaUnknown status
Jaslok Hospital and Research Centre
Coordinator of this site? Confirm its status
MumbaiIndiaUnknown status
Sir Ganga Ram Hospital
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Jehangir Hospital
Coordinator of this site? Confirm its status
PuneIndiaUnknown status
Fortis Hospital
Coordinator of this site? Confirm its status
West-MumbaiIndiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.