Saracatinib In Treating Patients With Previously Treated Metastatic Pancreatic Cancer

Study Overview

Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

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.

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.

Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer

DRUG: saracatinib
OTHER: pharmacogenomic studies
OTHER: pharmacological study
PROCEDURE: positron emission tomography
RADIATION: fludeoxyglucose F 18
OTHER: laboratory biomarker analysis

NCI-2009-00194
NCI-2009-00194 (REGISTRY Identifier) (REGISTRY: CTRP (Clinical Trial Reporting Program))
MAYO-MC0547
CDR0000610063
MC0547 (OTHER Identifier) (OTHER: Mayo Clinic)
7602 (OTHER Identifier) (OTHER: CTEP)
P30CA015083 (U.S. NIH Grant/Contract)
N01CM62205 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2008-08-14	Results First Submitted 2013-10-07	Last Update Submitted that met QC Criteria 2019-03-20
First Submitted that Met QC Criteria 2008-08-14	Results First Submitted that Met QC Criteria 2013-10-07	Last Update Posted (ACTUAL) 2019-04-02
First Posted (ACTUAL) 2008-08-15	Results First Posted 2013-12-05	Last Verified 2019-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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.	DRUG: saracatinib Given PO OTHER: pharmacogenomic studies Optional correlative studies OTHER: pharmacological study Optional correlative studies PROCEDURE: positron emission tomography Optional correlative studies RADIATION: fludeoxyglucose F 18 Optional correlative studies OTHER: laboratory biomarker analysis Optional correlative studies

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.

DRUG: saracatinib

Given PO

OTHER: pharmacogenomic studies

Optional correlative studies

OTHER: pharmacological study

Optional correlative studies

PROCEDURE: positron emission tomography

Optional correlative studies

RADIATION: fludeoxyglucose F 18

Optional correlative studies

OTHER: laboratory biomarker analysis

Optional correlative studies

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Overall Survival	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])	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	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 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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Wells Messersmith, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record