A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)

Gastrointestinal Stromal Tumors Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457743
• Other study ID #: A6181045
• Secondary ID: JapicCTI-070386
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 4, 2007
• Last updated: October 2, 2009
• Start date: January 2005
• Est. completion date: August 2008

Study information

• Verified date: October 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Sunitinib malate (SU011248)
SU011248

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chuo-ku	Tokyo
Japan	Pfizer Investigational Site	Kashiwa	Chiba
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Dose Limiting Toxicities (DLT)		Cycle 1 (Baseline to Week 6)	Yes
Primary	Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1		Day 1 of Cycle 1	No
Primary	Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28		Day 28 of Cycle 1	No
Primary	Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1		Day 1 of Cycle 1	No
Primary	Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28		Day 28 of Cycle 1	No
Primary	Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1		Day 1 of Cycle 1	No
Primary	Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28		Day 28 of Cycle 1	No
Primary	SU-011248 Clearance on Cycle 1 Day 28		Day 28 of Cycle 1	No
Primary	Accumulation Ratio (Rac) on Cycle 1 Day 28		Day 28 of Cycle 1	No
Primary	Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group		Day 28 of Cycles 1-4	No
Secondary	Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)		Day 1, 14, 28 of Cycles 1-4	No
Secondary	Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)		Day 1, 14, 28 of Cycles 1-4	No
Secondary	Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)		Day 1, 14, 28 of Cycles 1-4	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-011248		Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-012262		Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4	No
Secondary	Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662		Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4	No
Secondary	Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires		Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4	No
Secondary	Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires		Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4	No
Secondary	Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group		Day 28 of Cycles 1-4	No
Secondary	Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group		Day 28 of Cycles 1-4	No
Secondary	Time To Tumor Progression (TTP)		From the first dose to Progressive Disease	No
Secondary	Progression-Free Survival (PFS)		From the first dose to Progressive Disease or Death	No
Secondary	Time To Failure (TTF)		From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer.	No
Secondary	Overall Survival Time		From the first dose to death	No

External Links

•   To obtain contact information for a study center near you, click here.