Metastatic Colorectal CancerPhase 4NCT03564938
Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
A Phase 4 study testing Regorafenib (Stivarga, BAY73-4506) in people with Metastatic Colorectal Cancer, run by Bayer at 13 sites in India.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesIndia
- Study dates
- 30 Jul 2018to 1 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
India13 sites
Shalby Hospital
Ahmedabad, Gujarat, 380054
Healthcare Center Global Hospital
Ahmedabad, Gujarat, 380060
Sparsh Hospital & Critical Care
Bhubaneswar, Odisha, 751007
Apollo Research Foundation
Hyderabad, Andhra Pradesh, 500096
IPGME & R / SSKM Hospital
Kolkata, West Bengal, 700020
Health Point Hospital
Kolkata, West Bengal, 700025
Apollo Speciality Hospitals
Madurai, Tamil Nadu, 625020
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Jaslok Hospital and Research Centre
Mumbai, Maharashtra, 400026
Sushrut Hospital & Research Centre
Mumbai, Maharashtra, 400071
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Jehangir Hospital
Pune, Maharashtra, 411001
Fortis Hospital
West-Mumbai, Maharashtra, 400078
About this study
Official title: A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
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
- Metastatic Colorectal Cancer
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Keywords
- mCRC
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (Stivarga, BAY73-4506)Drug
Also called Nublexa
The recommended dose of regorafenib is 160 mg (consisting of 4 tablets, each containing 40 mg of regorafenib) for 3 weeks of every 4 week cycle, (ie. 3 weeks on therapy, 1 week off therapy).
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib (Stivarga, BAY 73-4506) | Experimental | Patients with metastatic colorectal cancer Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Measured: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
Measured: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body weight (kg)
Measured: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body height (cm)
Measured: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Systolic / Diastolic BP (mmHg)
Measured: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in heart rate (beats/min)
Measured: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Secondary outcomes (4)
Disease control rate (DCR)
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
Measured: 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
Overall response rate (ORR)
Defined as proportion of patients achieving CR, and PR per RECIST v.1.1
Measured: 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 (PFS)
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.
Measured: 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
Overall survival (OS)
Overall survival is defined as the time from study drug assignment to death from any cause or last date when the patient was known to be alive.
Measured: In each participant, every 8 weeks from the start of regorafenib until death, lost to follow-up, consent withdrawn or end of study, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start30 Jul 2018
- Primary completion20 Mar 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564938
- Sponsor's protocol ID
- 19214
- Status last verified
- Nov 2024
- First submitted
- 24 May 2018
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study to Investigate the Safety and Efficacy of Regorafenib in Indian Patients With Metastatic Colorectal Cancer (mCRC).
- ClinicalTrials.gov ID
- NCT03564938
- Acronym / sponsor ID
- 19214
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- mCRC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib (Stivarga, BAY 73-4506) | Experimental | Drug: Regorafenib (Stivarga, BAY73-4506)Patients with metastatic colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506)Also: NublexaThe recommended dose of regorafenib is 160 mg (consisting of 4 tablets, each containing 40 mg of regorafenib) for 3 weeks of every 4 week cycle, (ie. 3 weeks on therapy, 1 week off therapy). | Drug | Regorafenib (Stivarga, BAY 73-4506) |
Primary outcome
Number of Adverse Events
Time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Changes in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Percentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurements
Time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body weight (kg)
Time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Body height (cm)
Time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in Systolic / Diastolic BP (mmHg)
Time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
Change in heart rate (beats/min)
Time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
4 secondary outcomes
Disease control rate (DCR)
Time frame: 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
Overall response rate (ORR)
Time frame: 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 (PFS)
Time frame: 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
Overall survival (OS)
Time frame: In each participant, every 8 weeks from the start of regorafenib until death, lost to follow-up, consent withdrawn or end of study, whichever occurs first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Study\_Synopsis-19214.docx attachment has been generated from the Study Synopsis template. Data may be populated from the following (as available) : Study (255.0), Protocol (38.2), Results(0.1)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Regorafenib (Stivarga, BAY73-4506) in people with Metastatic Colorectal Cancer, run by Bayer at 13 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: From the start of regorafenib treatment up to 30 days after the last dose of regorafenib). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.