Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

NCT02450123 | Completed

• 1 other identifier: 2014-10-076
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors. This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression. To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.

Conditions

Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  expected average of 24 weeks

Secondary Outcomes (4)

• 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

Study Arms (1)

sunitinib

EXPERIMENTAL

sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.

Drug: sunitinib

Interventions

sunitinib DRUG

Also known as: sutene

sunitinib

Eligibility Criteria

• Age: 20 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 any study specific procedures.
• Patients must be ≥20 years of age.
• RET fusion positive,FGFR amplification, 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 ≥ 75 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.

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 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 sunitinib

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 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: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 21, 2015
• Study Start: March 23, 2016
• Primary Completion: August 30, 2019
• Study Completion: November 5, 2019
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)