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A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma

Inclusion Criteria:

- 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).

- 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

- 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

- 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

- 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).

Exclusion Criteria:

- 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.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

8 weeks after the 6th patient is enrolled

Safety Issue:


Principal Investigator

Andrew H. Ko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

June 2013

Related Keywords:

  • Pancreatic Cancer
  • pancreas
  • pancreatic
  • bosutinib
  • SKI-606
  • gemcitabine
  • gemzar
  • Patients with resected pancreatic cancer
  • Pancreatic Neoplasms



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115
Huntsman Cancer Institute, University of Utah Salt Lake City, Utah  84112