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AZD0530 in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
This study is currently recruiting participants.
Verified September 2010 by National Cancer Institute (NCI)

First Received on August 14, 2008.   Last Updated on September 30, 2010   History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00735917
  Purpose

RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well AZD0530 works in treating patients with previously treated metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: saracatinib
Other: laboratory biomarker analysis
Other: pharmacogenomic studies
Other: pharmacological study
Phase II

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 6-month survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Confirmed tumor response (complete or partial response) during first 6 courses of treatment [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to disease progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530.
  • To determine the adverse events of this drug in these patients.

Secondary

  • To evaluate the response rate in patients treated with this drug.
  • To evaluate the overall survival of patients treated with this drug.
  • To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and PET scans in a subset of patients.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also complete a medication diary.

Periodically, tumor biopsies for pharmacodynamic studies and limited pharmacokinetic blood sampling, plus pharmacogenomic studies are conducted.

After completion of study treatment, patients are followed up for 2 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • WBC ≥ 3,000/mm³
  • 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)
  • AST or 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
  • Urine protein:creatinine ratio ≤ 1.0
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Asymptomatic HIV allowed
  • Willingness to undergo 2 tumor biopsies
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
  • No prolonged QTc interval (i.e., ≥ 480 msec)
  • No other significant ECG abnormalities
  • No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 150 mm Hg or diastolic BP ≥ 90 mm Hg)
  • No concurrent cardiac dysfunction including, but not limited to, any of the following:

    • History of ischemic heart disease
    • Myocardial infarction
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
  • No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs ability to swallow AZD0530 tablets
  • No uncontrolled concurrent illness including, but not limited to any of the following:

    • Ongoing or active infection
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No other malignancy within the past 5 years, except curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy (< grade 2) (excluding alopecia) administered within the past 4 weeks
  • At least 3 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin)
  • At least 4 weeks since prior radiotherapy
  • More than 7 days since prior and no concurrent CYP3A4-active agents
  • No ongoing adverse events (excluding alopecia) due to chemotherapy or radiotherapy given more than 4 weeks prior to study
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • Concurrent low molecular weight heparin or full-dose coumadin allowed
  • Concurrent therapeutic hematopoietic growth factors allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735917

Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Florida
Mayo Clinic - Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute     313-576-9363        
United States, Minnesota
Minnesota Oncology Hematology, PA - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Patrick J. Flynn, MD     612-863-8585        
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Missouri
Center for Cancer Care and Research Recruiting
Saint Louis, Missouri, United States, 63141
Contact: John R. Eckardt, MD     314-628-1210     jeckardt@tcccr.com    
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Joel Picus, MD     314-362-5737        
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo     608-262-5223        
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth Recruiting
Perth, Western Australia, Australia, 6009
Contact: Michael Millward, MD     61-8-9346-3823     millward@cyllene.uwa.edu.au    
China
Prince of Wales Hospital Recruiting
Hong Kong, China
Contact: Brigette Ma, MD     852-2632-2989        
Singapore
Cancer Institute at National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Wei Peng Yong     65-6772-4670        
Johns Hopkins Singapore International Medical Centre Recruiting
Singapore, Singapore, 308433
Contact: Alex Y. Chang, MD     65-6880-2222     alexchang@imc.jhmi.edu    
National Cancer Centre - Singapore Recruiting
Singapore, Singapore, 169610
Contact: Toh Han Chong, MD, MBBS, MRCP     65-6436-8172        
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Wells Messersmith, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Charles Erlichman, Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00735917     History of Changes
Other Study ID Numbers: CDR0000610063, MAYO-MC0547
Study First Received: August 14, 2008
Last Updated: September 30, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on February 09, 2012