Clinical trial NCT00793871: Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Official title: A Single-arm, Open-label, Multi-center, Phase Iv, Efficacy And Safety Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Gastrointestinal Stromal Tumor After Disease Progression On Or Intolerance To Imatinib Mesylate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Keywords: sunitinib
Phase IV
gastrointestinal stomal tumor
imatinib resistant or intolerant
Chinese
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Baseline (Day 1) to death (up to 282 weeks)
measure: Objective Response Rate (ORR)
timeFrame: Baseline (Day 1) up to end of study treatment (up to 276 weeks)
measure: Time to Tumor Progression (TTP)
timeFrame: Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)
measure: Number of Participants With Abnormal Clinical Laboratory Measurements
timeFrame: Baseline up to 28 days post last administration of study drug
measure: Number of Participants With Significant Changes From Baseline in Physical Examination.
timeFrame: Baseline up to 28 days post last administration of study drug
measure: Number of Participants With Significant Vital Signs Changes From Baseline
timeFrame: Baseline (Day 1) up to 28 days post last administration of study drug
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline (Day 1), Last-on treatment visit (up to 28 days post last administration of study drug)
Other outcomes:
measure: Time to Tumor Response (TTR)
timeFrame: Baseline (Day 1) to tumor response (up to 82 weeks)
Locations:
city: Nanjing
country: China
facility: Nanjing Bayi Hospital
state: Jiangsu
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: 307 Hospital of PLA
city: Bejing
country: China
facility: Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: