Saracatinib in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00735917

First received: August 14, 2008

Last updated: April 25, 2014

Last verified: June 2013

History of Changes

Results First Received: October 7, 2013

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage IV Pancreatic Cancer
Interventions:	Drug: saracatinib Other: pharmacogenomic studies Other: pharmacological study Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Other: laboratory biomarker analysis

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Nineteen patients with gemcitabine-resistant metastatic pancreatic cancer were enrolled from four U.S. locations from October 2008 to January 2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 19 patients accrued to this study were used to report endpoints.

Reporting Groups

	Description
Treatment (Saracatinib)	Patients receive 175 mg/day saracatinib orally every day on days 1-28. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Participant Flow: Overall Study

	Treatment (Saracatinib)
STARTED	19
COMPLETED	19
NOT COMPLETED	0

Baseline Characteristics

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Outcome Measures

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1. Primary:

Six Month Survival [ Time Frame: Up to 6 months ]

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2. Secondary:

Overall Survival [ Time Frame: Up to 2 years ]

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3. Secondary:

Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR]) [ Time Frame: Evaluated using the first 6 courses of treatment ]

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4. Secondary:

Duration of Response [ Time Frame: 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 ]

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5. Secondary:

Progression-Free Survival [ Time Frame: Progression and survival status assessed every month, up to 2 years ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Wells A. Messersmith, M.D.
Organization: University of Colorado Cancer Center
e-mail: wells.messersmith@ucdenver.edu

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00735917 History of Changes
Obsolete Identifiers:	NCT01647035
Other Study ID Numbers:	NCI-2009-00194 NCI-2009-00194 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) MAYO-MC0547 CDR0000610063 MC0547 ( Other Identifier: Mayo Clinic ) 7602 ( Other Identifier: CTEP ) P30CA015083 ( U.S. NIH Grant/Contract ) N01CM62205 ( U.S. NIH Grant/Contract )
Study First Received:	August 14, 2008
Results First Received:	October 7, 2013
Last Updated:	April 25, 2014

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