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

NCT00457743 | Completed Phase 1 Results DMC

• 2 other identifiers: A6181045JapicCTI-070386
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Evaluate of RTD for Japanese GIST patients

Outcome Measures

Primary Outcomes (10)

• Number of Subjects With Dose Limiting Toxicities (DLT)

  Dose Limiting Toxicities(DLT) in the subjects enrolled in Phase 1.

  Cycle 1 (Baseline to Week 6)

• Maximum Plasma Concentration (Cmax) on Cycle 1 Day 1

  Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).

  Day 1 of Cycle 1

• Maximum Plasma Concentration (Cmax) on Cycle 1 Day 28

  Maximum Plasma Concentration (Cmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Cmax for total drug (SU-011248+SU-012662) was calculated as the mean of the Cmax of total drug from each individual subject (it is not the simple sum of means of Cmax of SU-011248 and SU-012662).

  Day 28 of Cycle 1

• Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 1

  Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).

  Day 1 of Cycle 1

• Area Under the Plasma Concentration Curve (AUC0-24) on Cycle 1 Day 28

  Area Under the Plasma Concentration Curve (AUC0-24) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The AUC0-24 for total drug (SU-011248+SU-012662) was calculated as the mean of the AUC0-24 of total drug from each individual subject (it is not the simple sum of means of AUC0-24 of SU-011248 and SU-012662).

  Day 28 of Cycle 1

• Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 1

  Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of median of Tmax of SU-011248 and SU-012662).

  Day 1 of Cycle 1

• Time to First Occurrence of Cmax (Tmax) on Cycle 1 Day 28

  Time to First Occurrence of Cmax (Tmax) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) in the subjects enrolled in Phase 1. The Tmax for total drug (SU-011248+SU-012662) was calculated as the median of the Tmax of total drug from each individual subject (it is not the simple sum of medians of Tmax of SU-011248 and SU-012662).

  Day 28 of Cycle 1

• SU-011248 Clearance on Cycle 1 Day 28

  SU-011248 Clearance in the subjects enrolled in Phase 1. Clearance was calculated by dividing a SU-011248 dose(mg) by AUC0-24(ng•h/mL).

  Day 28 of Cycle 1

• Accumulation Ratio (Rac) on Cycle 1 Day 28

  Accumulation Ratio (Rac) of SU-011248, its active metabolite SU-012662 and Total drug (SU-011248+SU-012662) on Cycle 1 Day 28 in the subjects enrolled in Phase 1. Rac was the ratio of Day 28 to Day 1.

  Day 28 of Cycle 1

• Number of Subjects With Clinical Benefit Response (CBR) Based on the Extramural Review Committee Assessment in Recommended Dose Group

  Clinical Benefit Response is defined as sum of subjects confirmed with complete response (CR), partial response (PR), or stable disease (SD)\>= 22 weeks on study according to Response Evaluation Criteria in Solid Tumors (RECIST).

  Day 28 of Cycles 1-4

Secondary Outcomes (14)

• Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)

  Day 1, 14, 28 of Cycles 1-4

• Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)

  Day 1, 14, 28 of Cycles 1-4

• Plasma Concentrations of Soluble Stem Cell Factor Receptor (sKIT)

  Day 1, 14, 28 of Cycles 1-4

• Trough Plasma Concentration (Ctrough) of SU-011248

  Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4

• Trough Plasma Concentration (Ctrough) of SU-012262

  Day 14, 28 of Cycle 1; Day 1, 14, 28 of Cycles 2-4

Study Arms (1)

SU011248

EXPERIMENTAL

25 , 50 or 75 mg/day of SU011248

Drug: Sunitinib malate (SU011248)

Interventions

Sunitinib malate (SU011248) DRUG

SU011248

SU011248

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Kashiwa, Chiba, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Suita, Osaka, Japan

Location

Pfizer Investigational Site

Chuo-ku, Tokyo, Japan

Location

Related Links

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

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2007
• First Posted: April 6, 2007
• Study Start: January 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 13, 2009
• Results First Posted: November 13, 2009

Record last verified: 2009-10

Locations

JP (4)