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

NCT02691767 | Completed

• 1 other identifier: 2016-02-096
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  24 months

Secondary Outcomes (4)

• Overall response rate

  24 months

• Time to progression

  24 months

• Overall survival

  24 months

• Number of subjects with adverse events as a measure of safety

  24 months

Study Arms (1)

pazopanib

EXPERIMENTAL

pazopanib 800 mg will be administered orally daily every 3weeks

Drug: pazopanib

Interventions

pazopanib DRUG

pazopanib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

pazopanib

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: February 25, 2016
• Study Start: May 1, 2016
• Primary Completion: January 16, 2018
• Study Completion: February 13, 2020
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)