An International Phase 2 Study Of SU011248 In Patients With Advanced / Metastatic Gastric Cancer Failing Chemotherapy - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Stomach Neoplasms
Intervention:	Drug: Sunitinib

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study used a Simon 2-stage design with objective response rate (ORR) as the primary efficacy endpoint. Enrollment was halted after Part 1 Stage 2 because the minimum number of responding subjects required to proceed to Part 2 was not reached. Further subject enrollment therefore ended after 78 subjects had been enrolled and treated on Part 1.

Reporting Groups

	Description
50 mg Sunitinib	Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.

Description

50 mg Sunitinib

Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.

Participant Flow: Overall Study

	50 mg Sunitinib
STARTED	78
COMPLETED	2
NOT COMPLETED	76
Death	8
Adverse Event	11
Lack of Efficacy	55
Withdrawal by Subject	2

Baseline Characteristics

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Reporting Groups

	Description
50 mg Sunitinib	Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.

Description

50 mg Sunitinib

Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.

Baseline Measures

	50 mg Sunitinib
Number of Participants [units: participants]	78
Age [units: years] Mean ± Standard Deviation	55.1 ± 12.4
Gender [units: participants]
Female	22
Male	56

Outcome Measures

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1. Primary:

Best Overall Response [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]

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2. Primary:

Objective Response (Complete Response (CR) or Partial Response (PR)) [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]

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3. Secondary:

Clinical Benefit Response (CBR)-Complete Response (CR), Partial Response (PR) or Stable Disease (SD) With Duration ≥ 24 Weeks [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or clinical benefit response for at least 24 weeks on study ]

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4. Secondary:

Duration of Response (CR or PR) [ Time Frame: Day 28 of Cycle 1 and Day 28 of Cycles thereafter or death due to cancer ]

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5. Secondary:

Progression-Free Survival [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter or death ]

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6. Secondary:

Time to Tumor Progression (TTP) [ Time Frame: From start of study treatment until Day 28 of Cycle 1, Day 28 of Cycles thereafter ]

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7. Secondary:

Overall Survival [ Time Frame: From start of study treatment until death ]

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Serious Adverse Events

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Other Adverse Events

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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. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.

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
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00226811 History of Changes
Other Study ID Numbers:	A6181054
Study First Received:	September 23, 2005
Results First Received:	May 14, 2009
Last Updated:	December 10, 2009
Health Authority:	United States: Food and Drug Administration