Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

NCT00793871 | Completed Phase 4 Results

• 1 other identifier: A6181177
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.

Conditions

Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors

Keywords

sunitinib; Phase IV; gastrointestinal stomal tumor; imatinib resistant or intolerant; Chinese

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS was defined as the time (in weeks) from the date of the first treatment to the date of the first documentation of objective tumor progression or death due to any cause, whichever occurred first. Participants last known to be 1) alive, 2) on study treatment or discontinued study treatment, but haven't yet started a new anticancer treatment and 3) progression-free were censored at the date of the last objective disease assessment that verified lack of disease progression. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.0), as a \>=20% increase in the sum of the longest dimensions of the target lesions taking as a reference the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions.

  Baseline (Day 1) up to disease progression or death whichever occurred first (up to 264 weeks)

Secondary Outcomes (7)

• Overall Survival (OS)

  Baseline (Day 1) to death (up to 282 weeks)

• Objective Response Rate (ORR)

  Baseline (Day 1) up to end of study treatment (up to 276 weeks)

• Time to Tumor Progression (TTP)

  Baseline (Day 1) up to objective tumor progression or death due to tumor progression (up to 264 weeks)

• Number of Participants With Abnormal Clinical Laboratory Measurements

  Baseline up to 28 days post last administration of study drug

• Number of Participants With Significant Changes From Baseline in Physical Examination.

  Baseline up to 28 days post last administration of study drug

Other Outcomes (1)

• Time to Tumor Response (TTR)

  Baseline (Day 1) to tumor response (up to 82 weeks)

Study Arms (1)

sunitinib

EXPERIMENTAL

single agent sunitinib, single arm

Drug: Sunitinib Malate (SU011248)

Interventions

Sunitinib Malate (SU011248) DRUG

Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.

sunitinib

Eligibility Criteria

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

You may qualify if:

• Histologically-proven diagnosis of malignant GIST (Gastrointestinal Stromal Tumors).
• Evidence of unidimensionally measurable disease
• Failure of prior treatment with imatinib or intolerant to imatinib
• Male or female, 18 years of age or older.
• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
• Resolution of all acute toxic effects
• Adequate organ function.

You may not qualify if:

• Anticancer treatment after last dose of imatinib
• Major surgery within 4 weeks or radiation therapy within 2 weeks.
• Grade 3 hemorrhage within 4 weeks prior to starting the study treatment.
• Diagnosis of second malignancy within the last 5 years.
• History of brain disease.
• Cardiac disease within 12 months.
• Thyroid function abnormality.
• Ongoing cardiac dysrhythmias.
• Uncontrolled hypertension.
• Ongoing treatment with anticoagulant and CYP3A4 inhibitors and inducers.
• HIV or AIDS related illness.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Nanjing Bayi Hospital

Nanjing, Jiangsu, 210002, China

Location

Cancer Institute & Hospital Chinese Academy of Medical Sciences and PUMC

Beijing, 100021, China

Location

Beijing Cancer Hospital

Beijing, 100035, China

Location

307 Hospital of PLA

Beijing, 100071, China

Location

Related Links

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

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumors

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

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

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.gov_Inquiries@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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 20, 2015
• Results First Posted: May 1, 2015

Record last verified: 2015-10

Locations

CN (4)