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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00457743
First received: April 4, 2007
Last updated: October 2, 2009
Last verified: October 2009

April 4, 2007
October 2, 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) ] [ 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 ]
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 ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00457743
A6181045, JapicCTI-070386
Yes
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