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| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Biomarker screening portion of study:
PATIENT CHARACTERISTICS:
No concurrent cardiac dysfunction including, but not limited to, any of the following:
No uncontrolled concurrent illness including, but not limited to any of the following:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |
| Study Chair: | Wells Messersmith, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| 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 |
|
recurrent pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas |
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |