Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00793871
First received: November 17, 2008
Last updated: July 30, 2014
Last verified: July 2014

November 17, 2008
July 30, 2014
November 2008
April 2014   (final data collection date for primary outcome measure)
Progression-Free Survival (PFS) [ Time Frame: from enrollment to disease progress or death ] [ Designated as safety issue: No ]
The period from study entry until disease progression, death or date of last contact.
Progression-Free Survival (PFS) [ Time Frame: from enrollment to disease progress or death ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00793871 on ClinicalTrials.gov Archive Site
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs); [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.Type, incidence, severity graded by [NCI] CTCAE, timing, seriousness, and relatedness of adverse events, laboratory abnormalities, physical examination findings, vital signs, weight and ECOG
  • Overall survival (OS) [ Time Frame: from enrollment to death ] [ Designated as safety issue: No ]
  • Overall objective response rate (ORR) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]
  • Time to tumor response (TTP) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]
  • Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0), timing, seriousness, and relatedness of adverse events, laboratory abnormalities, physical examination [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]
  • findings, vital signs, weight and ECOG performance status [ Time Frame: from signing the consent form to 28 days after end of study treatment ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: from enrollment to death ] [ Designated as safety issue: No ]
  • Overall objective response rate (ORR) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]
  • Time to tumor response (TTP) [ Time Frame: from enrollment to objective response ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
A Single-Arm, Open-Label, Multi-Center, Phase IV, Safety And Efficacy Study Of Sunitinib Malate In The Treatment Of Chinese Patients With Imatinib Mesylate-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Drug: Sunitinib Malate (SU011248)
Subjects will receive treatment with sunitinib in repeated 6-week cycles (4 weeks on, 2 weeks off), at a starting dose of 50 mg.
Experimental: sunitinib
single agent sunitinib, single arm
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
60
June 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00793871
A6181177
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

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