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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457743
First Posted: April 6, 2007
Last Update Posted: November 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
April 4, 2007
April 6, 2007
July 16, 2009
November 13, 2009
November 13, 2009
January 2005
August 2008   (Final data collection date for primary outcome measure)
  • Number of Subjects With Dose Limiting Toxicities (DLT) [ Time Frame: Cycle 1 (Baseline to Week 6) ]
  • Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1 [ Time Frame: Day 1 of Cycle 1 ]
  • Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ]
  • Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1 [ Time Frame: Day 1 of Cycle 1 ]
  • Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ]
  • Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1 [ Time Frame: Day 1 of Cycle 1 ]
  • Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ]
  • SU-011248 Clearance on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ]
  • Accumulation Ratio (Rac) on Cycle 1 Day 28 [ Time Frame: Day 28 of Cycle 1 ]
  • 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 ]
PhaseI:The incidence of all adverse events by type and grade;Pharmacokinetics (1st, 14th and 28th day of every cycle). PhaseII: Anti-tumor activity (every 6 weeks and end of treatment);The incidence of all adverse events by type and grade.
Complete list of historical versions of study NCT00457743 on ClinicalTrials.gov Archive Site
  • Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) [ Time Frame: Day 1, 14, 28 of Cycles 1-4 ]
  • Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2) [ Time Frame: Day 1, 14, 28 of Cycles 1-4 ]
  • Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT) [ Time Frame: Day 1, 14, 28 of Cycles 1-4 ]
  • Trough Plasma Concentration (Ctrough) of SU-011248 [ Time Frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 ]
  • Trough Plasma Concentration (Ctrough) of SU-012262 [ Time Frame: Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Time To Tumor Progression (TTP) [ Time Frame: From the first dose to Progressive Disease ]
  • Progression-Free Survival (PFS) [ Time Frame: From the first dose to Progressive Disease or Death ]
  • Time To Failure (TTF) [ Time Frame: From the first dose to Progressive Disease, Treatment discontinuation except completion of treatment, or Death due to cancer. ]
  • Overall Survival Time [ Time Frame: From the first dose to death ]
Pharmacodynamic indices (every 2 weeks) Abnormal laboratory changes (every 2 weeks) Patient-reported outcomes;
Not Provided
Not Provided
 
A Phase I/II Study of Sunitinib Malate (SU011248) In Patients With Gastrointestinal Stromal Tumor (GIST)
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.

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
Drug: Sunitinib malate (SU011248)
SU011248
Experimental: SU011248
25 , 50 or 75 mg/day of SU011248
Intervention: Drug: Sunitinib malate (SU011248)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2008
August 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00457743
A6181045
JapicCTI-070386
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP