Colorectal NeoplasmsPhase 2NCT02465502
Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer
A Phase 2 study testing Regorafenib (Stivarga, BAY73-4506) in people with Colorectal Neoplasms, run by Bayer at 1 site in Brazil.
Trial summary
To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks) of regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory to standard therapies and who were never exposed to antiangiogenic therapy. 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
- 59 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jul 2015to 11 Dec 2017
- Phase
- Phase 2
- 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;
- Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
- Subjects with metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to standard chemotherapy based on fluoropyrimidine, oxaliplatin, irinotecan, and an anti-EGFR therapy if RAS wild-type. This progression must be during or within 4 months following the last administration of standard therapies.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate bone-marrow, liver, and renal function
- Women of childbearing potential and men must agree to use adequate contraception when sexually active during the study and for at least 8 weeks after the last study drug administration.
Who cannot join
- Prior treatment with an antiangiogenic agent;
- Congestive heart failure of New York Heart Association (NYHA) class 2 or worse;
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug;
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management);
- Ongoing acute or chronic infection (> Grade 2 NCI-CTCAE v 4.03);
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- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism (except for adequately treated catheter-related venous thrombosis occurring more than one month before the start of study medication) events within 6 months of study enrollment. Subjects being treated with low-weight heparin are allowed to participate as long as dose is limited to prophylactic use.
- Any history of or currently known brain metastases (head CT/MRI will be performed during screening period if brain metastases are suspected)
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years before study entry, except for curatively treated cervical cancer in situ, in situ ductal breast cancer, non-melanoma skin cancer and superficial bladder tumors;
- Last chemotherapy dose or any other anti-cancer therapy administered in less than 4 weeks from start of study treatment;
- Use of therapeutic anticoagulation;
- Proteinuria > 3.5 g/24 hours measured by urine protein-creatinine ratio from a random urine sample (Grade 3, NCI-CTCAE v 4.03) on urinalysis screening result. If there is medical history of proteinuria, previous urinalysis results should be considered and/or performed so at least 2 results separated by at least 2 weeks are available;
- History of interstitial lung disease with ongoing signs and symptoms at the time of informed consent;
- Non-healing wound, non-healing ulcer, or non-healing bone fracture;
- Subjects with evidence or history of any bleeding diathesis, irrespective of severity;
- Any hemorrhage or bleeding event ≥ Grade 3 NCI-CTCAE v 4.03 within 4 weeks prior to the start of study medication;
- Known history of human immunodeficiency virus (HIV) infection;
- History of active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy;
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Uncontrolled, Open-label Phase IIb Trial of Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer
To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks) of regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory to standard therapies and who were never exposed to antiangiogenic therapy.
- Conditions
- Colorectal Neoplasms
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Keywords
- Colorectal cancer, Regorafenib
- 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
Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib (BAY73-4506) | Experimental | Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants without disease progression or death at the end of 8 weeks
Measured: At week 8
Secondary outcomes (6)
Progression-Free Survival (PFS)
PFS is defined as the date from the first dose of regorafenib until radiologic and/or clear clinical progression or death from any cause, whichever comes first.
Measured: Approximately 2 months
Overall Survival (OS)
OS is defined as the date from the first dose of regorafenib until death by any cause.
Measured: Approximately 2 months
Overall Response Rate (ORR)
ORR is defined as the proportion of subjects with the best tumor response (confirmed PR or CR) that is achieved during or within 30 days after therapy.
Measured: Approximately 2 months
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects who have a best response rating over the whole duration of the study of CR, PR, or SD.
Measured: Approximately 2 months
Metabolic response measured by [18F] fluorodeoxyglucose positron emission tomography (FDG PET)
Measured: Approximately 2 months
Percentage of participants with grade 1 or higher adverse events, using NCI Common Terminology Criteria for Adverse Events (CTC-AE) Version 4.03
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start21 Jul 2015
- Primary completion2 May 2017
- Study completion11 Dec 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT02465502
- Sponsor's protocol ID
- 17217
- Status last verified
- Nov 2018
- First submitted
- 4 Jun 2015
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Riechelmann RP, Leite LS, Bariani GM, Glasberg J, Rivelli TG, da Fonseca LG, Nebuloni DR, Braghiroli MI, Queiroz MA, Isejima AM, Kappeler C, Kikuchi L, Hoff PM. Regorafenib in Patients with Antiangiogenic-Naive and Chemotherapy-Refractory Advanced Colorectal Cancer: Results from a Phase IIb Trial. Oncologist. 2019 Sep;24(9):1180-1187. doi: 10.1634/theoncologist.2019-0067. Epub 2019 Jun 7.
PubMed 31175167
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Uncontrolled, Open-label Phase IIb Trial of Regorafenib in Subjects With Antiangiogenic-naive and Chemotherapy-refractory Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02465502
- Acronym / sponsor ID
- 17217
- Conditions
- Colorectal Neoplasms
- Keywords
- Colorectal cancer, Regorafenib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2015 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 8 Jun 2015 (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.
To determine the efficacy (as measured by progression-free survival [PFS] rate at 8 weeks) of regorafenib in subjects with metastatic colorectal cancer (CRC) whose disease is refractory to standard therapies and who were never exposed to antiangiogenic 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 (BAY73-4506) | Experimental | Drug: Regorafenib (Stivarga, BAY73-4506)Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects ≥18 years of age;
- Histological or cytological confirmation of adenocarcinoma of the colon or/and rectum;
- Subjects with metastatic colorectal cancer (CRC) whose disease progressed or who were intolerant to standard chemotherapy based on fluoropyrimidine, oxaliplatin, irinotecan, and an anti-EGFR therapy if RAS wild-type. This progression must be during or within 4 months following the last administration of standard therapies.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (19 listed)
- Prior treatment with an antiangiogenic agent;
- Congestive heart failure of New York Heart Association (NYHA) class 2 or worse;
- Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study drug;
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg despite optimal medical management);
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)Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). | Drug | Regorafenib (BAY73-4506) |
Primary outcome
Percentage of participants without disease progression or death at the end of 8 weeks
Time frame: At week 8
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Approximately 2 months
Overall Survival (OS)
Time frame: Approximately 2 months
Overall Response Rate (ORR)
Time frame: Approximately 2 months
Disease Control Rate (DCR)
Time frame: Approximately 2 months
Metabolic response measured by [18F] fluorodeoxyglucose positron emission tomography (FDG PET)
Time frame: Approximately 2 months
Percentage of participants with grade 1 or higher adverse events, using NCI Common Terminology Criteria for Adverse Events (CTC-AE) Version 4.03
Time frame: Approximately 2 months
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 7 Nov 2018.
- Derived from this study: PubMed 31175167Riechelmann RP, Leite LS, Bariani GM, Glasberg J, Rivelli TG, da Fonseca LG, Nebuloni DR, Braghiroli MI, Queiroz MA, Isejima AM, Kappeler C, Kikuchi L, Hoff PM. Regorafenib in Patients with Antiangiogenic-Naive and Chemotherapy-Refractory Advanced Colorectal Cancer: Results from a Phase IIb Trial. Oncologist. 2019 Sep;24(9):1180-1187. doi: 10.1634/theoncologist.2019-0067. Epub 2019 Jun 7.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regorafenib (Stivarga, BAY73-4506) in people with Colorectal Neoplasms, run by Bayer at 1 site in Brazil.
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 7 inclusion and 19 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 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of participants without disease progression or death at the end of 8 weeks (time frame: At week 8). 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 NCT02465502, 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 7 Nov 2018.