Pancreatic Neuroendocrine TumorsPhase 2NCT01121562
Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
A Phase 2 study testing Sunitinib in people with Pancreatic Neuroendocrine Tumors, run by Pfizer at 4 sites in Japan.
Trial summary
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumors
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesJapan
- Study dates
- Jul 2010to Nov 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor)
Who cannot join
- Patients with poorly differentiated neuroendocrine cancer are not eligible
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
National Cancer Center Hospital
Chuo-ku, Tokyo
Kyushu University Hospital
Fukuoka, Fukuoka
Aichi Cancer Center Central Hospital
Nagoya, Aichi-ken
Osaka Police Hospital
Osaka, Osaka
About this study
Official title: A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
The purpose of the study is to evaluate the effect of Sunitinib on the clinical benefit response rate.
- Conditions
- Pancreatic Neuroendocrine Tumors
- Being tested
- Sunitinib
- Keywords
- Neuroendocrine tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Sunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days)
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib arm | Experimental | Not described Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Response Rate (CBR)
CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks.
Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.
Measured: Up to 799 days of treatment
Secondary outcomes (5)
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response of confirmed CR or confirmed PR. Based on the response evaluation criteria in solid tumors (RECIST), CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion.
Measured: Up to 799 days of treatment
Tumor Shrinkage
Tumor shrinkage is defined as the percent change from baseline for the sum of the longest diameter of target lesions in participants.
Measured: Up to 799 days of treatment
Progression-free Survival (PFS)
PFS is defined as the time from registration to first documentation of progressive disease (PD) or to death due to any cause, whichever occurs first.
Measured: Up to 799 days of treatment
Overall Survival (OS)
Overall Survival (OS) is defined as the time from registration to documentation of death due to any cause.
Measured: Up to 3 years from the last subject registration to the study
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).
Reference dose is 37.5 mg. Dose-corrected concentration is calculated from the following formula, "observed concentration multiplied by 37.5" over "actual dose".
SU012662 is an active metabolite of sunitinib.
Measured: Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011
- Study completionNov 2013
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 Pancreatic Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121562
- Sponsor's protocol ID
- A6181193
- Status last verified
- Jun 2014
- First submitted
- 10 May 2010
- Last updated
- 30 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ito T, Okusaka T, Nishida T, Yamao K, Igarashi H, Morizane C, Kondo S, Mizuno N, Hara K, Sawaki A, Hashigaki S, Kimura N, Murakami M, Ohki E, Chao RC, Imamura M. Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor. Invest New Drugs. 2013 Oct;31(5):1265-74. doi: 10.1007/s10637-012-9910-y. Epub 2012 Dec 27.
PubMed 23269537
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Sunitinib In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT01121562
- Acronym / sponsor ID
- A6181193
- Conditions
- Pancreatic Neuroendocrine Tumors
- Keywords
- Neuroendocrine tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Posted 27 Aug 2012
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 evaluate the effect of Sunitinib on the clinical benefit response rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib arm | Experimental | Drug: Sunitinib |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET (Neuroendocrine Tumor)
Key exclusion criteria (1 listed)
- Patients with poorly differentiated neuroendocrine cancer are not eligible
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 |
|---|---|---|
| SunitinibSunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days) | Drug | Sunitinib arm |
Primary outcome
Clinical Benefit Response Rate (CBR)
Time frame: Up to 799 days of treatment
CBR rate is defined as the percentage of participants with a best overall response of confirmed complete response (CR), confirmed partial response (PR) ,or stable disease (SD) ≥ 24 weeks. Based on RECIST, CR is defined as the disappearance of all target lesions and PR is defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesion. SD is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest dimensions since the treatment started.
5 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 799 days of treatment
Tumor Shrinkage
Time frame: Up to 799 days of treatment
Progression-free Survival (PFS)
Time frame: Up to 799 days of treatment
Overall Survival (OS)
Time frame: Up to 3 years from the last subject registration to the study
Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).
Time frame: Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23269537Ito T, Okusaka T, Nishida T, Yamao K, Igarashi H, Morizane C, Kondo S, Mizuno N, Hara K, Sawaki A, Hashigaki S, Kimura N, Murakami M, Ohki E, Chao RC, Imamura M. Phase II study of sunitinib in Japanese patients with unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumor. Invest New Drugs. 2013 Oct;31(5):1265-74. doi: 10.1007/s10637-012-9910-y. Epub 2012 Dec 27.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Sunitinib in people with Pancreatic Neuroendocrine Tumors, run by Pfizer at 4 sites in Japan.
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 1 inclusion and 1 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 30 Jun 2014. 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 Japan. 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 27 Aug 2012). 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?
Clinical Benefit Response Rate (CBR) (time frame: Up to 799 days of 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 NCT01121562, 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 30 Jun 2014.