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

Sponsor:	Pfizer
Information provided by (Responsible Party):	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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

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

U.S. FDA Resources

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] CTCAE, timing, seriousness, and relatedness of adverse events, laboratory abnormalities, physical examination 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
Experimental: sunitinib 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

Locations

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

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
ClinicalTrials.gov Identifier:	NCT00793871 History of Changes
Other Study ID Numbers:	A6181177
Study First Received:	November 17, 2008
Last Updated:	May 3, 2012
Health Authority:	China: State Food and Drug Administration

Keywords provided by Pfizer:

sunitinib
Phase IV
gastrointestinal stomal tumor
imatinib resistant or intolerant
Chinese

Additional relevant MeSH terms:

Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Stromal Tumors
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Imatinib
Sunitinib
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2012