Clinical trial NCT00457743: A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
Official title: A Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Stromal Tumors
Keywords: Evaluate of RTD for Japanese GIST patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-06
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I;To investigate the clinically recommended dose of Sunitinib malate (SU011248) following multiple oral dosing in the first cycle (4 consecutive weeks and 2 weeks rest) by reviewing the safety and tolerability.

Phase II;To determine the objective tumor response and the safety of Sunitinib malate (SU011248) at the clinically recommended dose.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically-confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST).
* Patients previously treated with imatinib mesylate.

Exclusion Criteria:

* Patients who have not recovered from the acute toxic effects of previous antineoplastic therapy or treatment with imatinib mesylate.
* Any tumor therapy for gastrointestinal stromal tumor (GIST) discontinued less than 4 weeks prior to starting study treatment. Imatinib mesylate discontinued less than 2 weeks prior to starting therapy.

Primary outcomes:
measure: Number of Subjects With Dose Limiting Toxicities (DLT)
timeFrame: Cycle 1 (Baseline to Week 6)
measure: Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1
timeFrame: Day 1 of Cycle 1
measure: Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28
timeFrame: Day 28 of Cycle 1
measure: Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1
timeFrame: Day 1 of Cycle 1
measure: Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28
timeFrame: Day 28 of Cycle 1
measure: Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1
timeFrame: Day 1 of Cycle 1
measure: Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28
timeFrame: Day 28 of Cycle 1
measure: SU-011248 Clearance on Cycle 1 Day 28
timeFrame: Day 28 of Cycle 1
measure: Accumulation Ratio (Rac) on Cycle 1 Day 28
timeFrame: Day 28 of Cycle 1
measure: Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group
timeFrame: Day 28 of Cycles 1-4
Secondary outcomes:
measure: Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
timeFrame: Day 1, 14, 28 of Cycles 1-4
measure: Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
timeFrame: Day 1, 14, 28 of Cycles 1-4
measure: Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)
timeFrame: Day 1, 14, 28 of Cycles 1-4
measure: Trough Plasma Concentration (Ctrough) of SU-011248
timeFrame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
measure: Trough Plasma Concentration (Ctrough) of SU-012262
timeFrame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
measure: Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662
timeFrame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4
measure: Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires
timeFrame: Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4
measure: Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires
timeFrame: Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4
measure: Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group
timeFrame: Day 28 of Cycles 1-4
measure: Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group
timeFrame: Day 28 of Cycles 1-4
measure: Time To Tumor Progression (TTP)
timeFrame: From the first dose to Progressive Disease
measure: Progression-Free Survival (PFS)
timeFrame: From the first dose to Progressive Disease or Death
measure: Time To Failure (TTF)
timeFrame: From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.
measure: Overall Survival Time
timeFrame: From the first dose to death
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Suita
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Chuo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: