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
- Diseases
- Colorectal cancer
- 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
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Healthcare Center Global Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Shalby Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Sparsh Hospital & Critical Care Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
| Apollo Research Foundation Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Health Point Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| IPGME & R / SSKM Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Apollo Speciality Hospitals Coordinator of this site? Confirm its status | Madurai | India | Unknown status |
| Sushrut Hospital & Research Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Tata Memorial Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Jaslok Hospital and Research Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Sir Ganga Ram Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Jehangir Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Fortis Hospital Coordinator of this site? Confirm its status | West-Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.