Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02450136

Collaborator

(none)

Enrollment

Location

Arm

27.8

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Refractory Solid Tumors	Drug: pazopanib	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Oct 8, 2015

Actual Primary Completion Date :

Jul 30, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pazopanib pazopanib 800 mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.	Drug: pazopanib

Arm

Intervention/Treatment

Experimental: pazopanib

pazopanib 800 mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.

Drug: pazopanib

Outcome Measures

Primary Outcome Measures

progression-free survival [expected average of 24 weeks]

Secondary Outcome Measures

objective response rate [expected average of 24 weeks]
Time to progression [expected average of 24 weeks]
overall survival [expected average of 24 weeks]
Number of subjects with Adverse Events as a measure of toxicity profile [expected average of 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provision of fully informed consent prior to any study specific procedures.
Patients must be ≥20 years of age.
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.
ECOG performance status 0-2.
Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
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

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.
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 tumours 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joon Oh Park, MD,PhD, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT02450136

Other Study ID Numbers:

2015-01-135

First Posted:

May 21, 2015

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Study Results

No Results Posted as of Jun 15, 2022