Last reviewed · How we verify
NCT03564938
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
Phase 4 trial testing Regorafenib (Stivarga, BAY73-4506) in Metastatic Colorectal Cancer in 100 participants. Completed in 1 December 2023.
20 March 2023
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 30 July 2018 |
| Primary completion | 20 March 2023 |
| Estimated completion | 1 December 2023 |
| Sites | 13 locations across India |
Drugs / interventions tested
- Regorafenib (Stivarga, BAY73-4506) — full drug profile →
Conditions studied
- Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
Sponsor
Bayer — full company profile →
Who can join
18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Race as a Contributor to Stromal Modulation of Tumor Progression.
Kakarla M, ChallaSivaKanaka S, Hayward SW, Franco OE. · · 2021 · cited 12× · PMID 34071280 · DOI 10.3390/cancers13112656 -
Deciphering anti-colorectal cancer potential of Avicennia alba bioactives via network pharmacology and in vitro validation.
Irham LM, Adikusuma W, Illian DN, Mazaya M, et al · · 2025 · PMID 40745259 · DOI 10.1038/s41598-025-12500-x
Verify or expand the search:
- PubMed search for NCT03564938
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Regorafenib (Stivarga, BAY73-4506)
Trials testing the same drug.
- NCT06137170 — A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Col · completed
- NCT06321055 — An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal T · completed
- NCT06246643 — A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer S · Phase 2 · active not recruiting
- NCT06029010 — An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metast · completed
- NCT04696055 — Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With · Phase 2 · completed
Other recruiting trials for Metastatic Colorectal Cancer
Currently open trials in the same condition.
- NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
- NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
- NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
- NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
- NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03564938 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 3 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03564938.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing