Colorectal NeoplasmsPhase 3REGARDNCT01853319
Regorafenib in Subjects With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
A Phase 3 study testing Regorafenib (Stivarga, BAY73- 4506) in people with Colorectal Neoplasms, run by Bayer at 11 sites in Turkey (Türkiye).
Trial summary
This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- 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
- 11 sitesTurkey (Türkiye)
- Study dates
- 24 Jul 2013to 11 Jun 2018
- Phase
- Phase 3
- 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 subjects >/= 18 years of age
- Life expectancy of at least 3 months
- Histological or cytological documentation of adenocarcinoma of the colon or rectum
- Subjects with metastatic colorectal cancer (Stage IV)
- Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements
- Women of childbearing potential and men must agree to use adequate contraception since signing of the inform consent (IC) form until at least 3 months after the last study drug administration
Who cannot join
- Prior treatment with regorafenib
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
- Pregnant or breast-feeding subjects
- Congestive heart failure >/= New York Heart Association (NYHA) class 2
- Myocardial infarction less than 6 months before start of study drug
- Ongoing infection > Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v. 4.0
- Renal failure requiring hemo-or peritoneal dialysis
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Turkey (Türkiye)11 sites
Study site
Ankara, 06100
Study site
Ankara, 06500
Study site
Antalya
Study site
Balcali/Adana, 01330
Study site
Bursa
Study site
Gaziantep, 27010
Study site
Istanbul, 34093
Study site
Istanbul, 34899
Study site
Izmir, 35100
Study site
Kayseri
Study site
Samsun
About this study
Official title: An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
This is an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.
- Conditions
- Colorectal Neoplasms
- Being tested
- Regorafenib (Stivarga, BAY73- 4506)
- Keywords
- Regorafenib, Metastatic colorectal cancer
- 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
160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib | Experimental | Regorafenib, 40 mg tablets 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 participants with adverse events as a measure of safety and tolerability
Measured: Up to 6 months
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
Measured: Up to 6 months
Number of death
Measured: Up to 6 months
Number of participants with serious adverse events as a measure of safety and tolerability
Measured: Up to 6 months
Progression-Free Survival (PFS)
The PFS is defined as the time from date of treatment assignment (i.e., date of first treatment) to date of first observed disease progression or death due to any cause, if death occurs while the subject is in the study (that is, by the last visit including during the safety follow-up visit date), and before progression is observed.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study start24 Jul 2013
- Primary completion24 Apr 2015
- Study completion11 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies 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 3
- 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
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01853319
- Sponsor's protocol ID
- 16754
- Acronym
- REGARD
- Status last verified
- Apr 2019
- First submitted
- 6 May 2013
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dane F, Ozgurdal K, Yalcin S, Benekli M, Aykan NF, Yucel I, Ozkan M, Evrensel T, Sevinc A, Coskun HS, Sanli UA, Kara IO, Yumuk PF. Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study. BMJ Open. 2020 Mar 26;10(3):e027665. doi: 10.1136/bmjopen-2018-027665.
PubMed 32220908
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase III Study of Regorafenib in Patients With Metastatic Colorectal Cancer (mCRC) Who Have Progressed After Standard Therapy
- ClinicalTrials.gov ID
- NCT01853319
- Acronym / sponsor ID
- REGARD / 16754
- Conditions
- Colorectal Neoplasms
- Keywords
- Regorafenib, Metastatic colorectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2013 (actual)
- Primary completion
- 24 Apr 2015 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 15 May 2013 (estimated)
- 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 an open-label phase III study of regorafenib in patients with metastatic colorectal cancer (mCRC) who have progressed after all approved standard therapy. The purpose of this study is to provide additional information about the safety profile of Regorafenib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib | Experimental | Drug: Regorafenib (Stivarga, BAY73- 4506)Regorafenib, 40 mg tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects >/= 18 years of age
- Life expectancy of at least 3 months
- Histological or cytological documentation of adenocarcinoma of the colon or rectum
- Subjects with metastatic colorectal cancer (Stage IV)
- Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab if KRAS WT (WT: wild-type i.e. no KRAS mutation)
Key exclusion criteria (7 listed)
- Prior treatment with regorafenib
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug
- Pregnant or breast-feeding subjects
- Congestive heart failure >/= New York Heart Association (NYHA) class 2
- Myocardial infarction less than 6 months before start of study drug
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)160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off) | Drug | Regorafenib |
Primary outcome
Number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to 6 months
Number of participants with adverse events which caused withdrawal, dose reduction, interruption or discontinuation
Time frame: Up to 6 months
Number of death
Time frame: Up to 6 months
Number of participants with serious adverse events as a measure of safety and tolerability
Time frame: Up to 6 months
Progression-Free Survival (PFS)
Time frame: Up to 6 months
The PFS is defined as the time from date of treatment assignment (i.e., date of first treatment) to date of first observed disease progression or death due to any cause, if death occurs while the subject is in the study (that is, by the last visit including during the safety follow-up visit date), and before progression is observed.
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 22 Apr 2019.
- Derived from this study: PubMed 32220908Dane F, Ozgurdal K, Yalcin S, Benekli M, Aykan NF, Yucel I, Ozkan M, Evrensel T, Sevinc A, Coskun HS, Sanli UA, Kara IO, Yumuk PF. Safety and efficacy of regorafenib in patients with treatment-refractory metastatic colorectal cancer in Turkey: the single-arm, open-label REGARD study. BMJ Open. 2020 Mar 26;10(3):e027665. doi: 10.1136/bmjopen-2018-027665.
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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.
Bayer Study Director study director
Bayer
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regorafenib (Stivarga, BAY73- 4506) in people with Colorectal Neoplasms, run by Bayer at 11 sites in Turkey (Türkiye).
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 8 inclusion and 7 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Turkey (Türkiye). 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 participants with adverse events as a measure of safety and tolerability (time frame: Up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01853319, which also lists 1 linked publication.
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 22 Apr 2019.