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A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer


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.


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.


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.

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

- 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

- 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

- Ongoing or active infection

- Psychiatric illness or social situations that would limit compliance with study

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients alive at 6 months

Outcome Description:

If patients are lost to follow-up prior to the time required for the applicable primary endpoint, we will consider reporting the final point estimate of the primary endpoint via the method of Kaplan and Meier (1958) which accounts for the censoring of such data at the date of last contact (last known alive). Otherwise, ninety percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

Wells Messersmith

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Mayo ClinicRochester, Minnesota  55905
Washington University School of MedicineSaint Louis, Missouri  63110
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Wayne State UniversityDetroit, Michigan  48202