Pancreatic CancerPhase 1NCT01025570
A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer
A Phase 1 study testing Gemcitabine, Bosutinib in people with Pancreatic Cancer, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back. 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?
- Gemcitabine, Bosutinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2010to Jun 2013
- Phase
- Phase 1
- 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
- Histologically proven adenocarcinoma of the pancreas.
- Complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). Positive microscopic margins are allowable.
- No measurable disease.
- ECOG performance status 0 - 1.
- ≥ 18 years of age.
- Ability to start adjuvant therapy within 8 weeks after pancreatic cancer surgery (but no sooner than 3 weeks).
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- CA 19-9 ≤ 2.5 times the upper limit of normal.
- ANC (absolute neutrophil count) ≥ 1500/μL
- Hemoglobin ≥ 9 gm/dL (may be transfused or may receive epoetin alfa to maintain this level)
- Platelet count ≥ 100,000/μL
- INR ≤ 1.5 (except those subjects who are receiving full-dose warfarin)
- Total bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times the upper limit of normal
- Serum creatinine ≤ 2.0
- Negative pregnancy test for women of childbearing potential (serum or urine beta-HCG).
- All patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
- Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards.
- At least one paraffin block from patient's pancreatic cancer surgery must be available for analysis (does not necessarily need to be received by the start of study treatment).
Who cannot join
- Any prior systemic or investigational therapy for pancreatic cancer.
- Grossly positive surgical margins.
- Any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula.
- History of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications.
- Serious active ongoing infection, including any requiring parenteral antibiotics.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse.
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- Pregnancy (positive pregnancy test) or lactation.
- Known central nervous system disease.
- Inability to swallow pills/tolerate oral intake.
- Inability to comply with study and/or follow-up procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma
The purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back.
- Conditions
- Pancreatic Cancer
- Being tested
- Gemcitabine, Bosutinib
- Keywords
- pancreas, pancreatic, bosutinib, SKI-606, gemcitabine, gemzar, Patients with resected pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine, BosutinibDrug
Gemcitabine, 1000 mg/m2 on D1,8,15 over 30 mins standard infusion rate Bosutinib 400 mg, oral, once daily
| Study group | Role | What they receive |
|---|---|---|
| Gem/Bos | Experimental | Gemcitabine 1000 mg/m2, D1,8,15 of each cycle
Bostutinib 400 mg daily concurrently with Gemcitabine Receives: Drug: Gemcitabine, Bosutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer.
Measured: 8 weeks after the 6th patient is enrolled
To estimate the median disease-free survival rate of patients with completely resected pancreatic cancer treated with this combination
Measured: 2 years after last patient is enrolled
Secondary outcomes (2)
To determine the overall survival rates of patients with completely resected pancreatic cancer when treated postoperatively with the combination of gemcitabine and bosutinib
Measured: 2 years after last patient is enrolled
To estimate both disease-free and overall survival at one and two years of patients with completely resected pancreatic cancer treated with this combination
Measured: 2 years after last patient is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMay 2010
- Primary completionMay 2012
- Study completionJun 2013
Why it stopped: Terminated due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Sponsor
- Investigators
- Andrew H. Ko, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025570
- Sponsor's protocol ID
- 09456
- Other IDs
- 10-00560
- Status last verified
- May 2014
- First submitted
- 1 Dec 2009
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT01025570
- Acronym / sponsor ID
- 09456
- Conditions
- Pancreatic Cancer
- Keywords
- pancreas, pancreatic, bosutinib, SKI-606, gemcitabine, gemzar, Patients with resected pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Dec 2009 (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.
The purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gem/Bos | Experimental | Drug: Gemcitabine, BosutinibGemcitabine 1000 mg/m2, D1,8,15 of each cycle Bostutinib 400 mg daily concurrently with Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically proven adenocarcinoma of the pancreas.
- Complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). Positive microscopic margins are allowable.
- No measurable disease.
- ECOG performance status 0 - 1.
- ≥ 18 years of age.
Key exclusion criteria (10 listed)
- Any prior systemic or investigational therapy for pancreatic cancer.
- Grossly positive surgical margins.
- Any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula.
- History of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications.
- Serious active ongoing infection, including any requiring parenteral antibiotics.
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 |
|---|---|---|
| Gemcitabine, BosutinibGemcitabine, 1000 mg/m2 on D1,8,15 over 30 mins standard infusion rate Bosutinib 400 mg, oral, once daily | Drug | Gem/Bos |
Primary outcome
To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer.
Time frame: 8 weeks after the 6th patient is enrolled
To estimate the median disease-free survival rate of patients with completely resected pancreatic cancer treated with this combination
Time frame: 2 years after last patient is enrolled
2 secondary outcomes
To determine the overall survival rates of patients with completely resected pancreatic cancer when treated postoperatively with the combination of gemcitabine and bosutinib
Time frame: 2 years after last patient is enrolled
To estimate both disease-free and overall survival at one and two years of patients with completely resected pancreatic cancer treated with this combination
Time frame: 2 years after last patient is enrolled
Results and safety
The study was stopped early (reason given: Terminated due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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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.
Andrew H. Ko, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gemcitabine, Bosutinib in people with Pancreatic Cancer, run by University of California, San Francisco at 2 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 18 inclusion and 10 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Terminated due to slow accrual). Results are not available in the source record.
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?
To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer. (time frame: 8 weeks after the 6th patient is enrolled). The study lists 2 primary outcomes in all. 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 9 May 2014.