Trial · NCT03564938
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
NCT03564938, Phase 4, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC). Trials, record NCT03564938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03564938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
- NCT number
- NCT03564938
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 100 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Regorafenib (Stivarga, BAY73-4506)
- First posted
- 2018-06-21
- Last updated
- 2024-12-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib | |
| Primary | Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib | |
| Primary | Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib | |
| Primary | Change in Body weight (kg) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib | |
| Primary | Change in Body height (cm) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib | |
| Primary | Change in Systolic / Diastolic BP (mmHg) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib | |
| Primary | Change in heart rate (beats/min) | From the start of regorafenib treatment up to 30 days after the last dose of regorafenib | |
| Secondary | Disease control rate (DCR) | In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first | Defined as proportion of patients achieving complete response (CR), partial response (PR), or SD (stable disease) per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 |
| Secondary | Overall response rate (ORR) | In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first | Defined as proportion of patients achieving CR, and PR per RECIST v.1.1 |
| Secondary | Progression free survival (PFS) | In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs first | Progression free survival is defined as the time from study drug assignment to progressive disease (PD) or death from any cause or date of last tumor assessment if the patient did not progress or die. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03564938
GET https://conductscience.org/api/trials/v1/NCT03564938/registered