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

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ClinicalTrials.gov Identifier: NCT02691793
Recruitment Status : Recruiting
First Posted : February 25, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Seung tae Kim, Samsung Medical Center

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
Refractory Solid Tumors Drug: Sunitinib Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
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 : November 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sunitinib
sunitinib 50 mg will be administered orally daily
Drug: Sunitinib
sunitinib 37.5mg QD




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 24 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02691793


Contacts
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Contact: Seung tae KIM, PhD 2-3410-3459 ext 82 seungtae1.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Seoul, Korea, Republic Of, Korea, Republic of, 135-710
Contact: yoonJeong Ahn    221487395 ext 82      
Principal Investigator: SeungTae Kim, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Seung tae Kim, Principal Investigator, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02691793     History of Changes
Other Study ID Numbers: 2016-02-098
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

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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:
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Neoplasms
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action