Description:
This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation
Refractory solid tumors.
This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors
harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally
once a day 28 days.Study treatment will be continued until objective disease progression.
To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring
FGFR2 Amplification or FGFR2 mutation.
Title
- Brief Title: Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors
- Official Title:
Clinical Trial IDs
- ORG STUDY ID:
2015-01-135
- NCT ID:
NCT02450136
Conditions
Interventions
Drug | Synonyms | Arms |
---|
pazopanib | | pazopanib |
Purpose
This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation
Refractory solid tumors.
This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors
harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally
once a day 28 days.Study treatment will be continued until objective disease progression.
To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring
FGFR2 Amplification or FGFR2 mutation.
Trial Arms
Name | Type | Description | Interventions |
---|
pazopanib | Experimental | pazopanib 800 mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression. | |
Eligibility Criteria
Inclusion Criteria:
1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. FGFR2 amplification or FGFR2 mutation Refractory Solid Tumors that has recurred or
progressed following standard therapy, or that has not responded to standard therapy,
or for which there is no standard therapy.
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by
investigator.
6. Adequate Organ Function Laboratory Values
- Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 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 subjects with liver metastases)
- creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures
(two forms of highly reliable methods) should not be breast feeding and must have a
negative pregnancy test prior to start of dosing.
8. Adequate heart function.
Exclusion Criteria:
1. Patients with second primary cancer, except: adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, or other solid tumours
curatively treated with no evidence of disease for ≤5 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. Any previous treatment with Pazopanib.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | progression-free survival |
Time Frame: | expected average of 24 weeks |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | objective response rate |
Time Frame: | expected average of 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Time to progression |
Time Frame: | expected average of 24 weeks |
Safety Issue: | |
Description: | |
Measure: | overall survival |
Time Frame: | expected average of 24 weeks |
Safety Issue: | |
Description: | |
Measure: | Number of subjects with Adverse Events as a measure of toxicity profile |
Time Frame: | expected average of 24 weeks |
Safety Issue: | |
Description: | |
Details
Phase: | N/A |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Samsung Medical Center |
Last Updated
January 22, 2020