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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02450123
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
43.4
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Mar 23, 2016
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Nov 5, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: sunitinib

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

Drug: sunitinib
Other Names:
  • sutene

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [expected average of 24 weeks]

    Secondary Outcome Measures

    1. objective response rate [expected average of 24 weeks]

    2. Time to progression [expected average of 24 weeks]

    3. overall survival [expected average of 24 weeks]

    4. 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:
    No
    Inclusion Criteria:

    1. Provision of fully informed consent prior to any study specific procedures.

    2. Patients must be ≥20 years of age.

    3. 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.

    4. ECOG performance status 0-2.

    5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.

    6. 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

    1. 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.

    2. Adequate heart function.

    Exclusion Criteria:

    1. 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.

    2. Has known active central nervous system (CNS) metastases.

    3. Has an active infection requiring systemic therapy.

    4. Pregnancy or breast feeding

    5. Patients with cardiac problem.

    6. Any previous treatment with sunitinib

    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:
    NCT02450123
    Other Study ID Numbers:
    • 2014-10-076
    First Posted:
    May 21, 2015
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 1, 2022
    Additional relevant MeSH terms:
    Sunitinib

    Study Results

    No Results Posted as of Jun 15, 2022