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CompletedNCT02691793Updated Jun 15, 2022

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

A Phase 4 interventional study of Sunitinib in Refractory Solid Tumors, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-06-15.

Sponsored by Samsung Medical Center · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Aug 2019, 7 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Refractory Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 1 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

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 sunitinib
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    sunitinib

    sunitinib 50 mg will be administered orally daily

    Drug: Sunitinib

Interventions

  • DrugSunitinib

    sunitinib 37.5mg QD

06

What researchers measure

Primary outcomes

  1. progression-free survival

    Time frame: 24 months

Secondary outcomes

  1. overall response rate

    Time frame: 24 months

  2. Time to progression

    Time frame: 24 months

  3. overall survival

    Time frame: 24 months

  4. Number of subjects with adverse events as a measure of safety

    Time frame: 24 months

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, Seoul, Korea, Republic Of 135-710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02691793
Lead sponsor
Samsung Medical Center
Responsible party
Seung tae Kim,PhMD (Principal Investigator, Samsung Medical Center) — Principal investigator
First posted
Feb 25, 2016
Start date
Nov 20, 2017
Primary completion
Aug 30, 2019
Completion
Nov 19, 2019
Last update
Jun 15, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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