Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor (GIST)
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00793871
First received: November 17, 2008
Last updated: May 6, 2013
Last verified: May 2013
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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:
Genetics Home Reference related topics:
gastrointestinal stromal tumor
MedlinePlus related topics:
Cancer
U.S. FDA Resources
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 ]
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 ]
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (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
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, 100035 | |
| Pfizer Investigational Site | |
| Beijing, China, 100071 | |
| 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: | May 6, 2013 |
| Health Authority: | China: 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 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 May 19, 2013