Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

NCT ID: NCT00735917

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-10-31

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.

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.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

saracatinib

Intervention Type: DRUG

Given PO

pharmacogenomic studies

Intervention Type: OTHER

Optional correlative studies

pharmacological study

Intervention Type: OTHER

Optional correlative studies

positron emission tomography

Intervention Type: PROCEDURE

Optional correlative studies

fludeoxyglucose F 18

Intervention Type: RADIATION

Optional correlative studies

laboratory biomarker analysis

Intervention Type: OTHER

Optional correlative studies

Interventions

saracatinib

Given PO

Intervention Type: DRUG

pharmacogenomic studies

Optional correlative studies

Intervention Type: OTHER

pharmacological study

Optional correlative studies

Intervention Type: OTHER

positron emission tomography

Optional correlative studies

Intervention Type: PROCEDURE

fludeoxyglucose F 18

Optional correlative studies

Intervention Type: RADIATION

laboratory biomarker analysis

Optional correlative studies

Intervention Type: OTHER

Other Intervention Names

AZD0530; Pharmacogenomic Study; pharmacological studies; FDG-PET; PET; PET scan; tomography, emission computed; 18FDG; FDG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wells Messersmith

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

University of Colorado at Denver

Aurora, Colorado, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

National University Hospital

Singapore, , Singapore

Countries

United States; Australia; Singapore

Other Identifiers

NCI-2009-00194

Identifier Type: REGISTRY

Identifier Source: secondary_id

MAYO-MC0547

Identifier Type: -

Identifier Source: secondary_id

CDR0000610063

Identifier Type: -

Identifier Source: secondary_id

MC0547

Identifier Type: OTHER

Identifier Source: secondary_id

7602

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

N01CM62205

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00194

Identifier Type: -

Identifier Source: org_study_id

NCT01647035

Identifier Type: -

Identifier Source: nct_alias