Study Of SU011248 Administered On A Continuous Daily Dosing Schedule In Patients With Gastrointestinal Stromal Tumor

NCT00137449 | Completed Phase 2 Results

• 1 other identifier: A6181047
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 4

Brief Summary

To evaluate the antitumor activity of SU011248 in advanced, imatinib mesylate-resistant gastrointestinal stromal tumor (GIST) when administered on a continuous daily dosing schedule

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Benefit Response (CBR) According to RECIST

  CBR is defined as a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) for at least 24 weeks on study according to RECIST. Confirmed responses are those that persisted on repeat imaging \>= 4 wks after initial response. Participants with no on-study radiographic tumor re-evaluation counted as non-responders.

  Planned duration on this protocol of up to 1 year

Secondary Outcomes (10)

• Number of Participants by Best Confirmed Response Category According to RECIST

  Planned duration on this protocol of up to 1 year

• Number of Participants With Overall Confirmed Objective Disease Response (ORR)

  Planned duration on this protocol of up to 1 year

• Duration of Stable Disease

  Planned duration on this protocol of up to 1 year

• Progression-free Survival (PFS)

  Planned duration on this protocol of up to 1 year

• Time to Tumor Progression (TTP)

  Planned duration on this protocol of up to 1 year

Study Arms (1)

A

EXPERIMENTAL

Drug: SU011248

Interventions

SU011248 DRUG

37.5 mg once daily on a continuous daily dosing schedule. Study medication continued as long as patient was obtaining clinical benefit, or until significant toxicity, or withdrawal of consent, for up to 1 year on study.

A

Eligibility Criteria

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

You may qualify if:

• Histopathologically proven diagnosis of malignant GIST that was not amenable to standard therapy.
• Failed prior treatment with imatinib mesylate, defined either by progression of disease (according to Response Evaluation Criterion in Solid Tumors (RECIST) or World Health Organization (WHO) criteria), or by significant toxicity during treatment with imatinib mesylate that precluded further treatment. Intolerance to prior imatinib mesylate therapy was defined as follows:
• Life-threatening adverse events (ie, Grade 4) at any dose (attempt to dose reduce or rechallenge not required) or Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day), specifically, Grade 2 toxicity that was unacceptable to the patient (such as nausea) that persisted despite standard countermeasures
• Evidence of unidimensionally measurable disease.

You may not qualify if:

• Previous treatment on a SU011248 clinical trial.
• Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma, that had been adequately treated with no evidence of recurrent disease for 12 months.
• History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
• Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
• Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade, or QTc interval \>450 msec for males or \>470 msec for females.
• Hypertension that could not be controlled by medications (\>150/100 mm/Hg despite optimal medical therapy).

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Lyon, 69373, France

Location

Pfizer Investigational Site

Villejuif, 94805, France

Location

Pfizer Investigational Site

Milan, 20133, Italy

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 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 29, 2005
• Study Start: September 1, 2005
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: September 15, 2009
• Results First Posted: September 4, 2009

Record last verified: 2009-09

Locations

US (1); FR (2); IT (1)