Clinical trial · Interventional
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).
NCT03564938CI-TRIAL-00083232completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Regorafenib (Stivarga, BAY 73-4506)
- description
- Patients with metastatic colorectal cancer
- interventionNames
- Drug: Regorafenib (Stivarga, BAY73-4506)
Primary outcomes (7)
- measure
- Number of Adverse Events
- timeFrame
- From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
- measure
- Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
- timeFrame
- From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
- measure
- Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.