- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00735917
Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530 (saracatinib).
II. To determine the adverse events of this drug in these patients.
SECONDARY OBJECTIVES:
I. To evaluate the response rate in patients treated with this drug. II. To evaluate the overall survival of patients treated with this drug. III. To explore the pharmacodynamic effects of AZD0530 with optional tumor biopsies, pharmacokinetic studies, and positron emission tomography (PET) scans in a subset of patients.
OUTLINE:
Patients receive saracatinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 2 years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Western Australia
-
Nedlands, Western Australia, Australia, 6009
- Sir Charles Gairdner Hospital
-
-
-
-
-
Singapore, Singapore, 119074
- National University Hospital
-
-
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado at Denver
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Wayne State University/Karmanos Cancer Institute
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Hospital and Clinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- Urine protein: creatinine ratio ≤ 1.0
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Asymptomatic human immunodeficiency virus (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 electrocardiogram (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 intravenous (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
- 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 cytochrome P450 3A4 (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (enzyme inhibitor therapy)
Patients 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.
|
Optional correlative studies
Given PO
Other Names:
Optional correlative studies
Other Names:
Optional correlative studies
Other Names:
Optional correlative studies
Other Names:
Optional correlative studies
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six Month Survival
Time Frame: Up to 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Up to 2 years
|
Overall survival time is defined as the time from registration to death due to any cause.
The median survival time and 95% confidence intervals will be estimated using the method of Kaplan-Meier.
|
Up to 2 years
|
Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])
Time Frame: Evaluated using the first 6 courses of treatment
|
A confirmed tumor response is defined to be a CR or PR noted as> the objective status on 2 consecutive evaluations at least 4 weeks apart. Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)> > Complete Response (CR): Disappearance of all non-nodal target lesions and each target lymph node must have a reduction in short axis to <1.0 centimeters.> > Partial response (PR): At least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the baseline sum of diameters. |
Evaluated using the first 6 courses of treatment
|
Duration of Response
Time Frame: 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
|
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented.
Estimated by the method of Kaplan-Meier.
|
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
Time Frame: Progression and survival status assessed every month, up to 2 years
|
Time from the date of registration to the date of progression or death, whichever occurs first.
Estimated by the method of Kaplan-Meier.
|
Progression and survival status assessed every month, up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wells Messersmith, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
- Saracatinib
Other Study ID Numbers
- NCI-2009-00194 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA015083 (U.S. NIH Grant/Contract)
- N01CM62205 (U.S. NIH Grant/Contract)
- MAYO-MC0547
- CDR0000610063
- MC0547 (Other Identifier: Mayo Clinic)
- 7602 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adenocarcinoma of the Pancreas
-
Centre Leon BerardMerck Sharp & Dohme LLC; Debiopharm International SACompletedAdenocarcinoma of the Pancreas | Adenocarcinoma of the Rectum | Adenocarcinoma of the ColonFrance
-
Samyang Biopharmaceuticals CorporationUnknownMetastatic Adenocarcinoma of the Pancreas | Recurrent Adenocarcinoma of the PancreasKorea, Republic of
-
Kyowa Hakko Kirin Pharma, Inc.Teva PharmaCompletedAdenocarcinoma of the Pancreas | Solid Tumour | Adenocarcinoma of the Colorectal
-
University of Michigan Rogel Cancer CenterCompletedAdenocarcinoma of the PancreasUnited States
-
National Cancer Institute, NaplesRecruitingAdenocarcinoma of the PancreasItaly, Spain
-
West Virginia UniversityRecruitingAdenocarcinoma of the PancreasUnited States
-
Baptist Health South FloridaAstraZenecaTerminatedAdenocarcinoma of the PancreasUnited States
-
Institut de Recherches Internationales ServierNot yet recruitingMetastatic Adenocarcinoma of the PancreasJapan
-
National Taiwan University HospitalRecruitingDuctal Adenocarcinoma of the PancreasTaiwan
-
Eastern Regional Medical CenterTerminatedMetastatic Adenocarcinoma of the PancreasUnited States
Clinical Trials on laboratory biomarker analysis
-
Children's Oncology GroupNational Cancer Institute (NCI)Completed
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)CompletedProstate Cancer
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingLeukemia | Acute Lymphoblastic Leukemia | Acute Promyelocytic LeukemiaUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedUntreated Adult Acute Lymphoblastic Leukemia | Untreated Childhood Acute Lymphoblastic LeukemiaUnited States, Canada, Australia, New Zealand, Puerto Rico, Switzerland
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Lymphoblastic Leukemia in Remission | Recurrent Childhood Acute Lymphoblastic LeukemiaUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)CompletedLung CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Completed
-
Children's Oncology GroupNational Cancer Institute (NCI)WithdrawnClear Cell Renal Cell Carcinoma | Rhabdoid Tumor of the Kidney | Congenital Mesoblastic Nephroma | Childhood Kidney NeoplasmUnited States
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)WithdrawnBreast Carcinoma | BRCA1 Mutation Carrier | BRCA2 Mutation CarrierUnited States
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedWilms Tumor and Other Childhood Kidney TumorsUnited States