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
  Purpose

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


Condition Intervention Phase
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Drug: Sunitinib Malate (SU011248)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: November 2008
Study Completion Date: June 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sunitinib
single agent sunitinib, single arm
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793871

Locations
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
China
Pfizer Investigational Site
Beijing, China, 100071
Pfizer Investigational Site
Beijing, China, 100035
Pfizer Investigational Site
Bejing, China, 100021
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00793871     History of Changes
Other Study ID Numbers: A6181177
Study First Received: November 17, 2008
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
sunitinib
Phase IV
gastrointestinal stomal tumor
imatinib resistant or intolerant
Chinese

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Gastrointestinal Stromal Tumors
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Imatinib
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014