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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

NCT02450123

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 2014-10-076
  • NCT ID: NCT02450123

Conditions

  • Refractory Solid Tumors

Interventions

DrugSynonymsArms
sunitinibsutenesunitinib

Purpose

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.

Trial Arms

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

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:progression-free survival
Time Frame:expected average of 24 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:objective response rate
Time Frame:expected average of 24 weeks
Safety Issue:
Description:
Measure:Time to progression
Time Frame:expected average of 24 weeks
Safety Issue:
Description:
Measure:overall survival
Time Frame:expected average of 24 weeks
Safety Issue:
Description:
Measure:Number of subjects with Adverse Events as a measure of toxicity profile
Time Frame:expected average of 24 weeks
Safety Issue:
Description:

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

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