Phase 4
N=60
Safety And Efficacy Study Of Sunitinib Malate In Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Bottom Line
View on ClinicalTrials.gov: NCT00793871 ↗Enrolled (actual)
60
Serious AEs
20.3%
Results posted
May 2015
Primary outcome: Primary: Progression-free Survival (PFS) — 46.4 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sunitinib Malate (SU011248) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
46.4 | — |
| SECONDARY Overall Survival (OS) |
111.3 | — |
| SECONDARY Objective Response Rate (ORR) |
19.0 | — |
| SECONDARY Time to Tumor Progression (TTP) |
47.3 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Measurements |
57 | — |
| SECONDARY Number of Participants With Significant Changes From Baseline in Physical Examination. |
28 | — |
| SECONDARY Number of Participants With Significant Vital Signs Changes From Baseline |
9; 1; 0; 0; 2; 2 | — |
| SECONDARY Eastern Cooperative Oncology Group (ECOG) Performance Status |
11; 48; 0; 0; 0; 0 | — |
Summary
To investigate safety and efficacy of single agent sunitinib malate in Chinese Patients With Imatinib Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00793871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.