Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer
7 other identifiers
interventional
19
3 countries
9
Brief Summary
This phase II trial is studying how well saracatinib works in treating patients with previously treated metastatic pancreatic cancer. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2008
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
August 15, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedResults Posted
Study results publicly available
December 5, 2013
CompletedApril 2, 2019
March 1, 2019
2.5 years
August 14, 2008
October 7, 2013
March 20, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Six Month Survival
The proportion of successes will be estimated by the number of surviving participants at 6 months divided by the total number of evaluable patients. A confidence interval for the 6-month survival rate was calculated using the exact binomial method.
Up to 6 months
Secondary Outcomes (4)
Overall Survival
Up to 2 years
Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])
Evaluated using the first 6 courses of treatment
Duration of Response
From the date first objective status is noted to be either a CR or PR to the date progression is documented, assessed up to 2 years
Progression-Free Survival
Progression and survival status assessed every month, up to 2 years
Study Arms (1)
Treatment (enzyme inhibitor therapy)
EXPERIMENTALPatients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Interventions
Optional correlative studies
Optional correlative studies
Optional correlative studies
Optional correlative studies
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Metastatic disease
- Received ≥ 1 prior chemotherapy regimen, preferably gemcitabine hydrochloride-based
- Biomarker screening portion of study:
- For subjects without archival tissue available (core biopsy or resection specimen; fine-needle aspirate samples only are not sufficient), must be willing to undergo a fresh needle-core biopsy of a safely biopsiable metastasis
- No known brain metastases
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
- White blood cell (WBC) ≥ 3,000/mm³
- Absolute neutrophil count (ANC) ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Total bilirubin \< 1.5 times upper normal limit (ULN) (patients may have been shunted in order to achieve normal bilirubin level)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 times ULN (\< 5 times ULN for patients with liver metastases)
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Urine protein \< 1,000 mg
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
University of Colorado at Denver
Aurora, Colorado, 80045, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
National University Hospital
Singapore, 119074, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wells A. Messersmith, M.D.
- Organization
- University of Colorado Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Wells Messersmith
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
August 15, 2008
Study Start
October 1, 2008
Primary Completion
April 1, 2011
Study Completion
October 1, 2012
Last Updated
April 2, 2019
Results First Posted
December 5, 2013
Record last verified: 2019-03