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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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.
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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

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1. Primary:

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

Measure Type	Primary
Measure Title	Six Month Survival
Measure Description	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.
Time Frame	Up to 6 months

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.

Measured Values

	Treatment (Saracatinib)
Participants Analyzed [Units: Participants]	19
Six Month Survival [Units: Percentage of patients] Number (95% Confidence Interval)	11 (1 to 33)

No statistical analysis provided for Six Month Survival

2. Secondary:

Overall Survival [ Time Frame: Up to 2 years ]

Measure Type	Secondary
Measure Title	Overall Survival
Measure Description	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.
Time Frame	Up to 2 years

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.

Measured Values

	Treatment (Saracatinib)
Participants Analyzed [Units: Participants]	19
Overall Survival [Units: Months] Median (95% Confidence Interval)	2.5 (1.3 to 3.6)

No statistical analysis provided for Overall Survival

3. Secondary:

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

Measure Type	Secondary
Measure Title	Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])
Measure Description	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.
Time Frame	Evaluated using the first 6 courses of treatment

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.

Measured Values

	Treatment (Saracatinib)
Participants Analyzed [Units: Participants]	19
Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR]) [Units: Participants]	0

No statistical analysis provided for Confirmed Tumor Responses (Complete Response [CR] or Partial Response [PR])

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 ]

Measure Type	Secondary
Measure Title	Duration of Response
Measure Description	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.
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

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 patients qualified for a confirmed response and therefore this endpoint was not analyzed.

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.

Measured Values

	Treatment (Saracatinib)
Participants Analyzed [Units: Participants]	0
Duration of Response

No statistical analysis provided for Duration of Response

5. Secondary:

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

Measure Type	Secondary
Measure Title	Progression-Free Survival
Measure Description	Time from the date of registration to the date of progression or death, whichever occurs first. Estimated by the method of Kaplan-Meier.
Time Frame	Progression and survival status assessed every month, up to 2 years

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.

Measured Values

	Treatment (Saracatinib)
Participants Analyzed [Units: Participants]	19
Progression-Free Survival [Units: Months] Median (95% Confidence Interval)	1.6 (0.9 to 1.8)

No statistical analysis provided for Progression-Free Survival

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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