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Adenocarcinoma of the PancreasPhase 2NCT00735917

Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

A Phase 2 study testing saracatinib, pharmacogenomic studies and pharmacological study in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, run by National Cancer Institute (NCI) at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
saracatinib, pharmacogenomic studies and pharmacological study
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
9 sitesin 3 countries
Study dates
Oct 2008to Oct 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 45Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

United States7 sites

  • University of Colorado at Denver

    Aurora, Colorado, 80045

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Australia1 site

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

Other trials in Australia

Singapore1 site

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Phase II Trial of AZD0530 in Previously Treated Metastatic Pancreas 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
saracatinib, pharmacogenomic studies, pharmacological study, positron emission tomography, fludeoxyglucose F 18
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • saracatinibDrug

    Also called AZD0530

    Given PO

  • pharmacogenomic studiesOther

    Also called Pharmacogenomic Study

    Optional correlative studies

  • pharmacological studyOther

    Also called pharmacological studies

    Optional correlative studies

  • positron emission tomographyProcedure or surgery

    Also called FDG-PET, PET, PET scan, tomography, emission computed

    Optional correlative studies

  • fludeoxyglucose F 18Radiation

    Also called 18FDG, FDG

    Optional correlative studies

  • laboratory biomarker analysisOther

    Optional correlative studies

Study groups in NCT00735917
Study groupRoleWhat they receive
Treatment (enzyme inhibitor therapy)ExperimentalPatients 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.
Receives: Drug: saracatinib; Other: pharmacogenomic studies; Other: pharmacological study; Procedure: positron emission tomography; Radiation: fludeoxyglucose F 18; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 6 months

Secondary outcomes (4)

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Evaluated using the first 6 courses of treatment

  3. 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.

    Measured: 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

  4. 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.

    Measured: Progression and survival status assessed every month, up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionApr 2011
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00735917
Sponsor's protocol ID
NCI-2009-00194
Other IDs
NCI-2009-00194, MAYO-MC0547, CDR0000610063, MC0547, 7602, P30CA015083, N01CM62205
Status last verified
Mar 2019
First submitted
14 Aug 2008
Last updated
2 Apr 2019

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing saracatinib, pharmacogenomic studies and pharmacological study in people with Adenocarcinoma of the Pancreas and Recurrent Pancreatic Cancer, run by National Cancer Institute (NCI) at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 45 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Australia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six Month Survival (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00735917.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.

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