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Completed

NCT Number: NCT02450136

Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors

This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors.

This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation Pazopanib 800mg will be administered orally once a day 28 days.Study treatment will be continued until objective disease progression.

To investigate the efficacy of Pazopanib in subjects with Refractory solid tumors harboring FGFR2 Amplification or FGFR2 mutation.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of fully informed consent prior to any study specific procedures.
  • Patients must be ≥20 years of age.
  • FGFR2 amplification or FGFR2 mutation 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.
  • ECOG performance status 0-2.
  • Have measurable or evaluated disease based on RECIST1.1. 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 subjects with liver metastases)
  • creatinine ≤1.5 x UNL
  • 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.
  • 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 tumours 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 Pazopanib.

Treatment and study plan

Pazopanib

Drug

Primary outcomes

  1. progression-free survival

    Time frame: expected average of 24 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 21, 2015
Registry last updated
Jun 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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