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

Hide Participant Flow

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

Hide Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.

Baseline Measures

	Treatment (Saracatinib)
Overall Participants Analyzed [Units: Participants]	19

Age [Units: Years] Median (Full Range)	63 (34 to 78)

Gender [Units: Participants]
Female	11
Male	8

Region of Enrollment [Units: Participants]
United States	19
Australia	0

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

Overall Survival [ Time Frame: Up to 2 years ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide Limitations and Caveats

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
No text entered.

More Information

Show More Information

To Top