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Trial record 30 of 180 for:    RET

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

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ClinicalTrials.gov Identifier: NCT02450123
Recruitment Status : Recruiting
First Posted : May 21, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Joon Oh Park, Samsung Medical Center

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
Refractory Solid Tumors Drug: sunitinib Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : March 23, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: sutene




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: expected average of 24 weeks ]

Secondary Outcome Measures :
  1. objective response rate [ Time Frame: expected average of 24 weeks ]
  2. Time to progression [ Time Frame: expected average of 24 weeks ]
  3. overall survival [ Time Frame: expected average of 24 weeks ]
  4. Number of subjects with Adverse Events as a measure of toxicity profile [ Time Frame: expected average of 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  7. 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.
  8. 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

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): NCT02450123


Contacts
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Contact: Joon Oh Park, MD,Ph.D. 2-3410-3459 ext 82

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Joon Oh Park, M.D., Ph.D    82 2 3410 3459    oncopark@skku.edu   
Contact: yoon Jeong Ahn    221487395 ext 82      
Sponsors and Collaborators
Samsung Medical Center

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Responsible Party: Joon Oh Park, MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02450123     History of Changes
Other Study ID Numbers: 2014-10-076
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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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