Description:
This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification
Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has
progressed following standard therapy or that has not responded to standard therapy or for
which there is no standard therapy.
To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.
Title
- Brief Title: Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors
- Official Title: Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
2016-02-096
- NCT ID:
NCT02691767
Conditions
Interventions
Drug | Synonyms | Arms |
---|
pazopanib | | pazopanib |
Purpose
This study is a single arm, pilot study of pazopanib in patient with FGFR2 amplification
Refractory solid tumor and/or specific sensitivity to pazopanib by Avatar scan that has
progressed following standard therapy or that has not responded to standard therapy or for
which there is no standard therapy.
To investigate the efficacy and safety of pazopanib in patient with Refractory solid tumor.
Trial Arms
Name | Type | Description | Interventions |
---|
pazopanib | Experimental | pazopanib 800 mg will be administered orally daily every 3weeks | |
Eligibility Criteria
Inclusion Criteria:
- Provision of fully informed consent prior to study specific procedures.
- Patients must be >= 19 years of age
- FGFR2 amplification ,Refractory solid tumor and/or specific sensitivity to by Avatar
scan that has progressed following standard therapy or that has not responded to
standard therapy or for which there is no standard therapy.
- ECOG Performance status0-2
- Have measurable or evaluated disease based on RECIST 1.1 as determined by
investigator.
- Adequate Organ Function Laboratory values
- Absolute neutrophil count >= 1.5 x 109/L, Hemoglobin >= 9g/dL,
pazopanibPlatelets>=100 x 109/L Bilirubin <= 1.5 x upper limit of normal AST/ALT
<= 2.5 X upper limit of normal(5.0 x upper limit of normal, for subject with
liver metastases) Creatinine<= 1.5 X UNL
- Patients of child-bearing potential should be using adequate contraceptive measures
should not be breast feeding and must have a negative pregnancy test prior to start of
dosing
- Adequate heart function
Exclusion Criteria:
- Patients with second primary cancer, except:adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumor
curatively treated with no evidence of disease for <= 5 years.
- Has known active central nervous system(CNS) metastases
- Has an active infection requiring systemic therapy
- Pregnancy or breast feeding
- Patients with cardiac problem
- Any previous treatment with pazopanib
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall response rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Time to progression |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Number of subjects with adverse events as a measure of safety |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Samsung Medical Center |
Last Updated
May 20, 2019