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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00735917




Registration number
NCT00735917
Ethics application status
Date submitted
14/08/2008
Date registered
15/08/2008
Date last updated
2/04/2019

Titles & IDs
Public title
Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Scientific title
A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas Cancer
Secondary ID [1] 0 0
NCI-2009-00194
Secondary ID [2] 0 0
NCI-2009-00194
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenocarcinoma of the Pancreas 0 0
Recurrent Pancreatic Cancer 0 0
Stage IV Pancreatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - saracatinib
Other interventions - pharmacogenomic studies
Other interventions - pharmacological study
Treatment: Surgery - positron emission tomography
Treatment: Other - fludeoxyglucose F 18
Other interventions - laboratory biomarker analysis

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.


Treatment: Drugs: saracatinib
Given PO

Other interventions: pharmacogenomic studies
Optional correlative studies

Other interventions: pharmacological study
Optional correlative studies

Treatment: Surgery: positron emission tomography
Optional correlative studies

Treatment: Other: fludeoxyglucose F 18
Optional correlative studies

Other interventions: laboratory biomarker analysis
Optional correlative studies

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Intervention code [4] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 6 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Evaluated using the first 6 courses of treatment
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Progression and survival status assessed every month, up to 2 years

Eligibility
Key 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 age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Wisconsin
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00735917
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Wells Messersmith
Address 0 0
Mayo Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications