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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00793871

Purpose

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

Condition	Intervention	Phase
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors	Drug: Sunitinib Malate (SU011248)	Phase IV

MedlinePlus related topics: Cancer

Drug Information available for: Imatinib Imatinib mesylate Sunitinib malate Sunitinib Malic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment
Official Title:	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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	60
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
sunitinib: Experimental single agent sunitinib, single arm	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793871

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations

China
Pfizer Investigational Site	Recruiting
Bejing, China, 100021
Pfizer Investigational Site	Recruiting
Beijing, China, 100035
Pfizer Investigational Site	Recruiting
Beijing, China, 100071
China, Jiangsu
Pfizer Investigational Site	Recruiting
Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181177
Study First Received:	November 17, 2008
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00793871 History of Changes
Health Authority:	China: State of Food and Drug Administration

Keywords provided by Pfizer:

sunitinib, Phase IV, gastrointestinal stomal tumor, imatinib resistant or intolerant, Chinese

Study placed in the following topic categories:

Imatinib
Digestive System Diseases
Digestive System Neoplasms
Sunitinib
Gastrointestinal Diseases

Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors
Angiogenesis Inhibitors
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Angiogenesis Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Imatinib
Neoplasms
Neoplasms by Site
Digestive System Diseases
Sunitinib
Therapeutic Uses
Gastrointestinal Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on March 16, 2009