Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02691767
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arm: 1
• Actual Duration (Months): 45.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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.

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
• Official Title: Study to Evaluate the Safety and Efficacy of Pazopanib, in Subject With Refractory Solid Tumors
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Jan 16, 2018
• Actual Study Completion Date: Feb 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pazopanib pazopanib 800 mg will be administered orally daily every 3weeks	Drug: pazopanib

Outcome Measures

Primary Outcome Measures

1. Progression-free survival [24 months]

Secondary Outcome Measures

1. Overall response rate [24 months]

2. Time to progression [24 months]

3. Overall survival [24 months]

4. Number of subjects with adverse events as a measure of safety [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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, Principal Investigator, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02691767
• Other Study ID Numbers: 2016-02-096
• First Posted: Feb 25, 2016
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jun 15, 2022