Pancreatic CancerPhase 2NCT02080260
A Study of Regorafenib in Advanced Pancreatic Cancer Patients
A Phase 2 study testing regorafenib in people with Pancreatic Cancer, run by Wake Forest University Health Sciences at 12 sites in United States.
Trial summary
This study tests regorafenib as a single agent in the treatment of metastatic pancreatic cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis for these patients is particularly grim, no other standard treatment options exist, and novel approaches are desperately needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic 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
- 20 participants
- Where
- 12 sitesUnited States
- Study dates
- 6 Jun 2014to 28 Jun 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
- Adenocarcinoma of the exocrine pancreas with metastatic disease.
- The site of the primary tumor confirmed to have been within the pancreas.
- Progression on at least one prior line of chemotherapy for locally-advanced or metastatic pancreatic cancer.
- Progression while on treatment with a gemcitabine regimen for advanced pancreatic cancer, or within 12 months of treatment with gemcitabine as part of adjuvant therapy.
- Measurable disease on axial imaging.
- Age greater than or equal to 18 years.
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- Life expectancy of at least 8 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2. Enrollment of patients with PS = 2 will be capped at 7 patients.
- Subjects must be able to understand and be willing to sign the written informed consent form.
- Acute toxic effects except alopecia of any prior treatment must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 1 or less.
- Adequate bone marrow, renal, and liver function.
- Warfarin or heparin will be allowed provided that there is no prior evidence of underlying coagulation abnormality.
- Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
- Patients (men and women) of childbearing potential must agree to use adequate contraception
- Patient must be able to swallow and retain oral medication.
Who cannot join
- Previous assignment to treatment during this study.
- Uncontrolled hypertension.
- Active clinically significant cardiac disease.
- Cerebrovascular arterial event within 6 months.
- Evidence or history of bleeding diathesis or coagulopathy.
- Any bleeding event greater than or equal to NCI CTCAE Grade 3 within 4 weeks.
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- New venous thrombotic or embolic events, such as deep vein thrombosis or pulmonary embolism within 3 months.
- Previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Patients surviving a cancer that was curatively treated and without evidence of disease for more than 3 years are allowed.
- Patients with pheochromocytoma.
- Known history of HIV infection or current chronic or active hepatitis B or C, requiring antiviral medication.
- Ongoing infection greater than or equal to Grade 2 NCI-CTCAE v4.0.
- Symptomatic metastatic brain or meningeal tumors.
- Presence of a non-healing wound, non-healing ulcer, or bone fracture.
- Renal failure requiring dialysis.
- Dehydration Grade greater than or equal to 1 NCI-CTCAE v4.0.
- Patients with seizure disorder requiring medication.
- Persistent proteinuria greater than or equal to Grade 3 NCI-CTCAE v4.0.
- Symptomatic interstitial lung disease.
- Pleural effusion or ascites that cause respiratory compromise.
- History of organ allograft except corneal transplant.
- Known or suspected allergy or hypersensitivity to the study drugs.
- Any severe, uncontrolled malabsorption condition.
- Women who are pregnant or breast-feeding.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study.
- Concurrent anti-cancer therapy other than study treatment (regorafenib).
- Prior use of regorafenib.
- Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days.
- Prior radiation therapy or hepatic arterial therapy is permitted if more than 4 weeks have passed since completion and measurable disease outside of the treated area is present, or if progression since treatment has occurred.
- Use of St. John's Wort.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Levine Cancer Institute-Albemarle
Albemarle, North Carolina, 28001
Low Country Hematology Oncology
Charleston, South Carolina, 29406
Levine Cancer Institute-South Tryon
Charlotte, North Carolina, 28203
Levine Cancer Institute
Charlotte, North Carolina, 28204
Levine Cancer Institute - Pineville
Charlotte, North Carolina, 28210
Levine Cancer Institute - Southpark
Charlotte, North Carolina, 28211
Levine Cancer Institute - Mallard Creek
Charlotte, North Carolina, 28262
Levine Cancer Institute - University
Charlotte, North Carolina, 28262
Levine Cancer Institute - Ballantyne
Charlotte, North Carolina, 28277
Levine Cancer Institute - Concord
Concord, North Carolina, 28025
Levine Cancer Institute-Monroe
Monroe, North Carolina, 28112
Levine Cancer Institute - Cleveland
Shelby, North Carolina, 28150
About this study
Official title: A Pilot Study Testing Single-Agent Regorafenib in Advanced Previously-Treated Adenocarcinoma of the Pancreas
This study tests regorafenib as a single agent in the treatment of metastatic pancreatic cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis for these patients is particularly grim, no other standard treatment options exist, and novel approaches are desperately needed.
Read the detailed description
This is a single arm, single stage Phase II study designed to evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer who have failed at least one prior line of therapy and treatment with gemcitabine. This study is open at the Levine Cancer Institute (LCI). A total of 32 patients will be enrolled over a two years. Following informed consent and eligibility check, all patients will start oral regorafenib therapy (120 mg daily for 3 weeks on / 1 week off; 28 day cycle) with a built-in dose escalation to 160mg after the first cycle as tolerated, and will continue therapy until progression or patient withdrawal. Patients will undergo radiological staging after the first two cycles of regorafenib therapy. Patients with progressive disease will be removed from the study. Patients who have at least stable disease will continue regorafenib therapy, at the Investigator's discretion, and will be radiologically restaged bimonthly.
- Conditions
- Pancreatic Cancer
- Being tested
- regorafenib
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regorafenibDrug
Also called Stivarga
Single agent drug therapy with regorafenib
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Oral Regorafenib Receives: Drug: regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects
16-week progression free survival was determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 16 weeks after treatment start, with progression defined radiographically using RECIST v1.1 or clinically based upon investigator assessment.
Measured: 16 weeks after enrollment
Secondary outcomes (4)
Progression Free Survival
PFS is defined as duration of time from enrollment to the study to time of progression or death. Disease progression (PD) can be objectively determined as per RECIST v1.1 (Response Evaluation Criteria in Solid Tumors, where PD is defined as a 20% increase in the sum of the longest diseased of target lesions, or a measurable increase in non-target lesion, or the appearance of new lesions) or progression can be subjective as determined by the investigator. Evidence for subjective progressions must be documented in medical records. For surviving subjects who do not have documented PD, PFS will be censored at last radiologic assessment. For subjects who receive subsequent anti-cancer therapy prior to documented PD, PFS will be censored at last radiologic assessment prior to commencement of subsequent therapy. Subjects who experience a PFS event following an interval equal to two or more scheduled CT assessments will be censored at date of last assessment prior to first missed assessment.
Measured: From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.
Overall Survival
Overall survival is defined as the duration from enrollment date to the date of death from any cause. Subjects who are alive or lost to follow-up at the time of the analysis will be censored at the last known date they were alive.
Measured: From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.
Overall Response
Overall response will be determined as the best treatment response for each patient as a binary variable indicating whether or not the patient achieved a Complete Response (CR) or Partial Response (PR) as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1):Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline. For the purposes of response determination, confirmatory scan for CR and PR is not required.
Measured: From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)
Disease Control
Disease control will be determined for each patient as a binary variable indicating whether or not the patient achieved a best overall best response of CR, PR, or stable disease as determined by RECIST v1.1 criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.1): Complete Response (CR) is the disappearance of all lesions (target and non target); Partial Response (PR) is at least 30% decrease in the sum of the diameters of target lesions from baseline and no new lesions or unequivocal progression in non target lesions from baseline; Stable Disease (SD) is neither sufficient shrinkage in target lesions to qualify for PR (less than 30% decrease) nor sufficient increase in target lesions (versus smallest sum of diameters) to qualify for PD (less than 20% increase), with no new lesions or unequivocal progression in non target lesions from baseline.
Measured: From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study start6 Jun 2014
- Primary completion28 Jun 2017
- Study completion28 Jun 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.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- John S Salmon, MD, Principal investigator, Atrium Health Levine Cancer InstituteEdward Kim, MD, Principal investigator, Atrium Health Levine Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080260
- Sponsor's protocol ID
- LCI-GI-PAN-REG-001
- Status last verified
- Jul 2019
- First submitted
- 3 Mar 2014
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Testing Single-Agent Regorafenib in Advanced Previously-Treated Adenocarcinoma of the Pancreas
- ClinicalTrials.gov ID
- NCT02080260
- Acronym / sponsor ID
- LCI-GI-PAN-REG-001
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 6 Jun 2014 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests regorafenib as a single agent in the treatment of metastatic pancreatic cancer patients who have progressed after prior chemotherapy with gemcitabine. The prognosis for these patients is particularly grim, no other standard treatment options exist, and novel approaches are desperately needed.
Detailed description
This is a single arm, single stage Phase II study designed to evaluate progression free survival (PFS) in patients with metastatic pancreatic cancer who have failed at least one prior line of therapy and treatment with gemcitabine. This study is open at the Levine Cancer Institute (LCI). A total of 32 patients will be enrolled over a two years. Following informed consent and eligibility check, all patients will start oral regorafenib therapy (120 mg daily for 3 weeks on / 1 week off; 28 day cycle) with a built-in dose escalation to 160mg after the first cycle as tolerated, and will continue therapy until progression or patient withdrawal. Patients will undergo radiological staging after the first two cycles of regorafenib therapy. Patients with progressive disease will be removed from the study. Patients who have at least stable disease will continue regorafenib therapy, at the Investigator's discretion, and will be radiologically restaged bimonthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: regorafenibOral Regorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Adenocarcinoma of the exocrine pancreas with metastatic disease.
- The site of the primary tumor confirmed to have been within the pancreas.
- Progression on at least one prior line of chemotherapy for locally-advanced or metastatic pancreatic cancer.
- Progression while on treatment with a gemcitabine regimen for advanced pancreatic cancer, or within 12 months of treatment with gemcitabine as part of adjuvant therapy.
- Measurable disease on axial imaging.
Key exclusion criteria (30 listed)
- Previous assignment to treatment during this study.
- Uncontrolled hypertension.
- Active clinically significant cardiac disease.
- Cerebrovascular arterial event within 6 months.
- 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: StivargaSingle agent drug therapy with regorafenib | Drug | Single Arm |
Primary outcome
Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects
Time frame: 16 weeks after enrollment
16-week progression free survival was determined for each subject as a binary variable indicating whether or not the subject is alive and progression free at 16 weeks after treatment start, with progression defined radiographically using RECIST v1.1 or clinically based upon investigator assessment.
4 secondary outcomes
Progression Free Survival
Time frame: From date of treatment start to date of progression or death, or censored as described above; assessed for approximately 3 years.
Overall Survival
Time frame: From date of treatment start to date of death, or censored as described above; assessed for approximately 3 years.
Overall Response
Time frame: From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)
Disease Control
Time frame: From enrollment to best response while on regorafenib; Subjects remained on treatment until disease progression or death or discontinuation from study or at least 28 days after last dose (subjects were on treatment for an average of 6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 S Salmon, MD principal investigator
Atrium Health Levine Cancer Institute
Edward Kim, MD principal investigator
Atrium Health Levine Cancer Institute
12 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 Pancreatic Cancer, run by Wake Forest University Health Sciences at 12 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 15 inclusion and 30 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 19 Jul 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?
Number of Patients Progression Free and Surviving at 16 Weeks as a Percent of All Enrolled Subjects (time frame: 16 weeks after enrollment). 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 21 Apr 2022.