Colon CancerPhase 2NCT02402036
A Biomarker Study in Patients Getting Regorafenib for Metastatic Colorectal Cancer
A Phase 2 study testing Regorafenib in people with Colon Cancer, run by Georgetown University at 1 site in United States.
Trial summary
This is an exploratory biomarker study. Patients with metastatic colorectal cancer will receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive 28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Metastatic colorectal cancer suitable for regorafenib treatment
- Life expectancy of at least 12 weeks
- Able to understand and willing to sign written informed consent form
- Adequate bone marrow, liver, and renal function
- Glomerular filtration rate >/= 60 according to the Modified Diet in Renal Disease abbreviated formula
- Women of childbearing potential must have a negative serum pregnancy test
- Subject able to swallow and retain oral medication
Who cannot join
- Previous assignment to treatment in this study
- Uncontrolled hypertension
- Active or clinically significant cardiac disease
- Evidence or history of Bleeding diathesis or coagulopathy
- Any hemorrhage or bleeding even Grade 3 or higher within 4 weeks prior to start of study medication
- Subjects with thrombotic, embolic, venous or arterial events
Show all 28Show fewer
- Subjects with any previously untreated or concurrent cancer
- Pheochromocytoma
- Known history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy
- Ongoing infection Grade 2 or higher
- Symptomatic metastatic brain or meningeal tumors
- Presence of a non-healing wound, non-healing ulcer, or bone fracture
- Renal failure requiring dialysis
- Dehydration Grade 1 or higher
- Seizure disorder requiring medication
- Persistent proteinuria Grade 3 or higher
- Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
- Pleural effusion or ascites that causes respiratory compromise
- History of organ allograft including corneal transplant
- Known or suspected allergy or hypersensitivity to the study drug
- Any malabsorption condition
- Women who are pregnancy or breast-feeding
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
- Concurrent anticancer therapy
- Concurrent use of another investigational drug or device therapy during or within 4 weeks of trial entry
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication
- Therapeutic anticoagulation with Vitamin-K antagonists or with heparins and heparinoids
- Use of any herbal remedy
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
Official title: Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study
This is an exploratory biomarker study. Patients with metastatic colorectal cancer will receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive 28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.
Read the detailed description
Tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed for phosphoproteins and RNA. Peripheral blood samples will be collected and banked for protein, miRNA, and mutated DNA analysis.
- Conditions
- Colon Cancer
- Being tested
- Regorafenib
- Medical subject headings
- Colonic 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 orally for 21 days every 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib | Experimental | Regorafenib 120 mg orally daily for 21 days out of a 28 day cycle Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum microRNA Quantification
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2017
- Study completionNov 2017
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 Colon CancerStudies of the same condition, open and under way.
- More trials run by Georgetown UniversityThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- John Marshall, MD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402036
- Sponsor's protocol ID
- 2014-0133
- Status last verified
- Nov 2017
- First submitted
- 4 Feb 2015
- Last updated
- 29 Jan 2019
- 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 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regorafenib in Metastatic Colorectal Cancer: An Exploratory Biomarker Study
- ClinicalTrials.gov ID
- NCT02402036
- Acronym / sponsor ID
- 2014-0133
- Conditions
- Colon Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Feb 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 29 Jan 2019
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 exploratory biomarker study. Patients with metastatic colorectal cancer will receive regorafenib, which is FDA approved in this setting, on day 1-21 of every consecutive 28 day cycle. Patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. Peripheral blood samples will be collected at baseline 2 weeks after starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.
Detailed description
Tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed for phosphoproteins and RNA. Peripheral blood samples will be collected and banked for protein, miRNA, and mutated DNA analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib | Experimental | Drug: RegorafenibRegorafenib 120 mg orally daily for 21 days out of a 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Metastatic colorectal cancer suitable for regorafenib treatment
- Life expectancy of at least 12 weeks
- Able to understand and willing to sign written informed consent form
- Adequate bone marrow, liver, and renal function
- Glomerular filtration rate >/= 60 according to the Modified Diet in Renal Disease abbreviated formula
Key exclusion criteria (28 listed)
- Previous assignment to treatment in this study
- Uncontrolled hypertension
- Active or clinically significant cardiac disease
- Evidence or history of Bleeding diathesis or coagulopathy
- Any hemorrhage or bleeding even Grade 3 or higher within 4 weeks prior to start of study medication
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 orally for 21 days every 28 day cycle | Drug | Regorafenib |
Primary outcome
Serum microRNA Quantification
Time frame: 2 years
Serum microRNAs will be quantified using miScript MiRNA PCR arrays
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- 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.
John Marshall, MD principal investigator
Georgetown University
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 in people with Colon Cancer, run by Georgetown University at 1 site 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 7 inclusion and 28 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: stopped early, as of the sponsor's last update on 29 Jan 2019. 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 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 29 Jan 2019). 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?
Serum microRNA Quantification (time frame: 2 years). 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 NCT02402036, 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 29 Jan 2019.