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

Purpose

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.

Condition	Intervention	Phase
Gastrointestinal Stromal Tumors	Drug: Sunitinib malate (SU011248)	Phase 1 Phase 2

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 Phase I/II Study of Sunitinib Malate (SU011248) In The Treatment of Patients With Malignant Gastrointestinal Stromal Tumor (GIST) Previously Treated by Imatinib Mesylate.

Resource links provided by NLM:

Genetics Home Reference related topics: gastrointestinal stromal tumor

MedlinePlus related topics: Cancer

Drug Information available for: Malic acid Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of Subjects With Dose Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (Baseline to Week 6) ] [ Designated as safety issue: Yes ]
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1 [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ] [ Designated as safety issue: No ]
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1 [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ] [ Designated as safety issue: No ]
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1 [ Time Frame: Day 1 of Cycle 1 ] [ Designated as safety issue: No ]
Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ] [ Designated as safety issue: No ]
SU-011248 Clearance on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ] [ Designated as safety issue: No ]
Accumulation Ratio (Rac) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ] [ Designated as safety issue: No ]
Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group [ Time Frame: Day 28 of Cycles 1-4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Day 1, 14, 28 of Cycles 1-4 ] [ Designated as safety issue: No ]
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) [ Time Frame: Day 1, 14, 28 of Cycles 1-4 ] [ Designated as safety issue: No ]
Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT) [ Time Frame: Day 1, 14, 28 of Cycles 1-4 ] [ Designated as safety issue: No ]
Trough Plasma Concentration (Ctrough) of SU-011248 [ Time Frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 ] [ Designated as safety issue: No ]
Trough Plasma Concentration (Ctrough) of SU-012262 [ Time Frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 ] [ Designated as safety issue: No ]
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 [ Time Frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 ] [ Designated as safety issue: No ]
Changes From Baseline of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Questionnaires [ Time Frame: Day 7, 14, 28, 35 of Cycle 1; Day 1, 7, 14, 28, 35 of Cycles 2-4 ] [ Designated as safety issue: No ]
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires [ Time Frame: Day 28 of Cycle 1; Day 1, 28 of Cycles 2-4 ] [ Designated as safety issue: No ]
Number of Subjects With Disease Controlled Based on the Extramural Review Committee Assessment in Recommended Dose Group [ Time Frame: Day 28 of Cycles 1-4 ] [ Designated as safety issue: No ]
Number of Subjects With Objective Response Based on the Extramural Review Committee Assessment in Recommended Dose Group [ Time Frame: Day 28 of Cycles 1-4 ] [ Designated as safety issue: No ]
Time To Tumor Progression (TTP) [ Time Frame: From the first dose to Progressive Disease ] [ Designated as safety issue: No ]
Progression-Free Survival (PFS) [ Time Frame: From the first dose to Progressive Disease or Death ] [ Designated as safety issue: No ]
Time To Failure (TTF) [ Time Frame: From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer. ] [ Designated as safety issue: No ]
Overall Survival Time [ Time Frame: From the first dose to death ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	January 2005
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SU011248 25 , 50 or 75 mg/day of SU011248	Drug: Sunitinib malate (SU011248) SU011248

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457743

Locations

Japan
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Suita, Osaka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan

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:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00457743 History of Changes
Other Study ID Numbers:	A6181045, JapicCTI-070386
Study First Received:	April 4, 2007
Results First Received:	July 16, 2009
Last Updated:	October 2, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Evaluate of RTD for Japanese GIST patients

Additional relevant MeSH terms:

Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Sunitinib

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013