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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02691793
Collaborator
(none)
1
1
1
24
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study to Evaluate the Safety and Efficacy of Sunitinib, in Subject With Refractory Solid Tumors
Actual Study Start Date :
Nov 20, 2017
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Nov 19, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: sunitinib

sunitinib 50 mg will be administered orally daily

Drug: Sunitinib
sunitinib 37.5mg QD

Outcome Measures

Primary Outcome Measures

  1. progression-free survival [24 months]

Secondary Outcome Measures

  1. overall response rate [24 months]

  2. Time to progression [24 months]

  3. overall survival [24 months]

  4. Number of subjects with adverse events as a measure of safety [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Seoul, Korea, Republic Of 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:
Seung tae Kim,PhMD, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT02691793
Other Study ID Numbers:
  • 2016-02-098
First Posted:
Feb 25, 2016
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022