Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00793871

First received: November 17, 2008

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2008

Last Updated Date

May 6, 2013

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Progression-Free Survival (PFS) [ Time Frame: from enrollment to disease progress or death ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00793871 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]
Overall survival (OS) [ Time Frame: from enrollment to death ] [ Designated as safety issue: No ]
Overall objective response rate (ORR) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]
Time to tumor response (TTP) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0), timing, seriousness, and relatedness of adverse events, laboratory abnormalities, physical examination [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]
findings, vital signs, weight and ECOG performance status [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]
Overall survival (OS) [ Time Frame: from enrollment to death ] [ Designated as safety issue: No ]
Overall objective response rate (ORR) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]
Time to tumor response (TTP) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Official Title ^ICMJE

A Single-Arm, Open-Label, Multi-Center, Phase IV, Safety And Efficacy Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Imatinib Mesylate-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

Brief Summary

To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors

Intervention ^ICMJE

Drug: Sunitinib Malate (SU011248)

Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

Study Arm (s)

Experimental: sunitinib

single agent sunitinib, single arm

Intervention: Drug: Sunitinib Malate (SU011248)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
Evidence of unidimensionally measurable disease
Failure of prior treatment with imatinib or intolerant to imatinib
Male or female, 18 years of age or older.
ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
Resolution of all acute toxic effects
Adequate organ function.

Exclusion Criteria:

Anticancer treatment after last dose of imatinib
Major surgery within 4 weeks or radiation therapy within 2 weeks.
Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
Diagnosis of second malignancy within the last 5 years.
History of brain disease.
Cardiac disease within 12 months.
Thyroid function abnormality.
Ongoing cardiac dysrhythmias.
Uncontrolled hypertension.
Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
HIV or AIDS related illness.
Pregnancy or breastfeeding.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00793871

Other Study ID Numbers ^ICMJE

A6181177

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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