Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Timepoint [1] 0 0
Up to 6 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])
Timepoint [2] 0 0
Evaluated using the first 6 courses of treatment
Secondary outcome [3] 0 0
Duration of Response
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
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
19
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00735917