Metastatic Colorectal CancerPhase 2NCT02466009
Regorafenib in Metastatic Colorectal Cancer
A Phase 2 study testing Regorafenib in people with Metastatic Colorectal Cancer, run by University of Rochester at 4 sites in United States.
Trial summary
The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Regorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2015to 9 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically confirmed colorectal adenocarcinoma
- Measurable metastatic disease.
- Age +/> 70
- Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
- Life expectancy >/= 12 weeks
- Able to understand and willing to sign written informed consent.
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- Laboratory requirements:
- Total bili ≤ 1.5 x upper limit or normal
- Alanine aminotransferase \& Asparate aminotransferase ≤ 2.5 x upper limit or normal
- Serum creatinine ≤ 1.5 x upper limit or normal
- International normalized ratio/prothrombin time ≤ 1.5 x upper limit or normal
- Platelet count ≥ 100,000, hemoglobin ≥ 9 g/dL
- Absolute neutrophil count ≥ 1,500. Blood transfusion to meet the inclusion criteria not be allowed.
- Glomerular filtration rate ≥ 60 ml/min
- Subjects of childbearing potential must agree to use adequate contraception beginning at the signing informed consent form until at least 3 months after the last dose of study drug.
- Must be able to swallow and retain oral medications
Who cannot join
- Currently receiving other systemic therapy for metastatic colorectal cancer
- Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
- Uncontrolled hypertension despite optimal medical management
- Active or clinically significant cardiac disease.
- Evidence or history of bleeding diathesis or coagulopathy
- Any hemorrhage or bleeding event ≥ grade 3 within 4 weeks.
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- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident, deep vein thrombosis or pulmonary embolus within 6 months of informed consent
- History of other active malignancy within past 2 years.
- Patients with phaeochromocytoma
- Known history of human immunodeficiency virus infection or current chronic/active hepatitis B or C infection.
- Ongoing infection > grade 2
- Symptomatic metastatic brain or meningeal tumors
- Presence of non-healing wound, non-healing ulcer, or bone fracture
- Renal failure requiring hemo- or peritoneal dialysis
- Dehydration ≥ grade 1
- Patients with seizure disorder requiring medication
- Persistent proteinuria ≥ grade 3 Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
- Pleural effusion or ascites that causes respiratory compromise, grade 2 dyspnea
- History of organ allograft including corneal transplant
- Known or suspected allergy or hypersensitivity to the study drug
- Any malabsorption condition
- Any condition which makes the subject unsuitable for trial participation
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic
Rochester, Minnesota, 55901
University of Rochester
Rochester, New York, 14642
About this study
Official title: Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study
The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.
Read the detailed description
Subjects will be asked to participate in the study because they are aged 70 or older and require treatment for colorectal cancer that has spread to other parts of the body and has not gotten better with other treatment. Subjects will undergo some initial tests to ensure that they meet all criteria necessary to participate in the study. Once the subject has completed initial testing and meets eligibility criteria, the subject will begin treatment with 120 mg of regorafenib (3 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks). After the first cycle, the doctor will discuss the possibility of increasing the dose to 160 mg (4 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks) based on the subjects health status. During the study, assessments will be performed to monitor the subjects tolerance and response to the treatment. Regorafenib will continue as long as the subject is tolerating the treatment and the subjects colorectal cancer is either responding to treatment or remains stable.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Regorafenib
- Keywords
- Colorectal cancer, metastatic colorectal cancer, colorectal adenocarcinoma
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Also called Stivarga
Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib | Experimental | 120 mg qd, 3 weeks on/1 week off (each cycle is 28 days)
Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast. Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.
Measured: From the date of study entry until 30 days after the last dose of study treatment.
Secondary outcomes (2)
Percentage of Subjects Who Responded to Study Treatment
Efficacy outcomes will be response rate (RR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS). A participant's best response will be classified per RECIST (Response evaluation criteria in solid tumors) criteria into complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). If a participant's best response was complete response, partial response, or stable disease they were classified as responding to treatment.
Measured: From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.
Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument
The FACT-C instrument is an 11 question survey that asks general questions about the participants digestive system. The instrument scores range from 0-44 with higher scores indicating digestive problems.
Measured: baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2019
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Aram Hezel, University of Rochester
- Investigators
- Aram Hezel, M.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466009
- Sponsor's protocol ID
- 55555
- Status last verified
- Aug 2024
- First submitted
- 9 Apr 2015
- Last updated
- 4 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.
PubMed 28712102
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regorafenib in Adults 70 Years or Older With Metastatic Colorectal Cancer: A Phase II Study
- ClinicalTrials.gov ID
- NCT02466009
- Acronym / sponsor ID
- 55555
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Colorectal cancer, metastatic colorectal cancer, colorectal adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2019 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to measure high grade (3-5) toxicity of regorafenib and to monitor the impact of treatment with regorafenib on the quality of life in older adults with metastatic colorectal cancer.
Detailed description
Subjects will be asked to participate in the study because they are aged 70 or older and require treatment for colorectal cancer that has spread to other parts of the body and has not gotten better with other treatment. Subjects will undergo some initial tests to ensure that they meet all criteria necessary to participate in the study. Once the subject has completed initial testing and meets eligibility criteria, the subject will begin treatment with 120 mg of regorafenib (3 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks). After the first cycle, the doctor will discuss the possibility of increasing the dose to 160 mg (4 tablets) each day for 21 days (3 weeks) in a 28 day cycle (4 weeks) based on the subjects health status. During the study, assessments will be performed to monitor the subjects tolerance and response to the treatment. Regorafenib will continue as long as the subject is tolerating the treatment and the subjects colorectal cancer is either responding to treatment or remains stable.
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: Regorafenib120 mg qd, 3 weeks on/1 week off (each cycle is 28 days) Three 40 mg tablets should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (< 30% fat) breakfast. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed colorectal adenocarcinoma
- Measurable metastatic disease.
- Age +/> 70
- Progression on standard therapy, not a candidate for further chemotherapy or patient declines other options
- Life expectancy >/= 12 weeks
Key exclusion criteria (23 listed)
- Currently receiving other systemic therapy for metastatic colorectal cancer
- Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
- Uncontrolled hypertension despite optimal medical management
- Active or clinically significant cardiac disease.
- Evidence or history of bleeding diathesis or coagulopathy
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 |
|---|---|---|
| RegorafenibAlso: StivargaRegorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets). | Drug | Regorafenib |
Primary outcome
Number of Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability.
Time frame: From the date of study entry until 30 days after the last dose of study treatment.
2 secondary outcomes
Percentage of Subjects Who Responded to Study Treatment
Time frame: From the date of completion of three cycles of treatment until the date of progression of disease as determined by restaging scans up to 2 years.
Mean Difference in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Instrument
Time frame: baseline and week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28712102Weinberg BA, Hartley ML, Salem ME. Precision Medicine in Metastatic Colorectal Cancer: Relevant Carcinogenic Pathways and Targets-PART 2: Approaches Beyond First-Line Therapy, and Novel Biologic Agents Under Investigation. Oncology (Williston Park). 2017 Jul 15;31(7):573-80.
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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.
Aram Hezel, M.D. principal investigator
University of Rochester
4 sites 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 in people with Metastatic Colorectal Cancer, run by University of Rochester at 4 sites in United States.
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 16 inclusion and 23 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 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Subjects Who Experience Grade 3-5 Toxicity as a Measure of Safety and Tolerability. (time frame: From the date of study entry until 30 days after the last dose of study treatment.). 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 NCT02466009, 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 4 Sep 2024.