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

NCT02691793 | Completed Phase 4 FDA Drug

• 1 other identifier: 2016-02-098
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single arm, pilot study of Sunitinib in patient with RET fusion positive, FGFR2 fusion/FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib 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 Sunitinib 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)

sunitinib

EXPERIMENTAL

sunitinib 50 mg will be administered orally daily

Drug: Sunitinib

Interventions

Sunitinib DRUG

sunitinib 37.5mg QD

sunitinib

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
• RET fusion positive or FGFR2 fusion/other FGFR mutation Refractory solid tumor and/or specific sensitivity to Sunitinib 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, 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 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 sunitinib

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, Korea, Republic of, 135-710, South Korea

Location

MeSH Terms

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: November 20, 2017
• Primary Completion: August 30, 2019
• Study Completion: November 19, 2019
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)