A Study to Determine the Safety of PRN1371 in Patients with Advanced Solid Tumors in Squamous Cell Lung Cancer and Bladder Cancer

What we are studying

The purpose of this study is to evaluate the investigational drug PRN1371. An investigational drug is one that has not been approved by the United States Food and Drug Administration. PRN1371 is a FGFR1-4 Kinase Inhibitor (fibroblast growth factor receptor that possess enzymatic activity as kinases), and is intended to inhibit tumor growth in some tumor types. The main purpose of this study is to: • test the safety and tolerability of PRN1371 in patients with advanced solid tumors; • to determine the best tolerated dose of PRN1371. Other goals of this study are to: • test how PRN1371 is processed by the body; • evaluate the clinical activity of PRN1371 in a smaller group of patients whose tumors have a FGFR1, 2, 3 or 4 genetic alterations; • assess the effect PRN1371 has on tumor size with CT or MRI scans; • test how a moderate fat meal affects the way the body processes PRN1371; • assess how particular mutations and the effectiveness and availability of PRN1371 are all related.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Cannot be pregnant or breastfeeding
  • Must have life expectancy of longer than 12 weeks
  • Able and willing to sign a written consent form
  • Able to comply with study procedures
  • Cannot have received prior treatment with FGFR inhibitor
  • Must have metastatic or recurrent disease and have failed first treatment
  • And cannot have history of strokes
  • Diabetes
  • Myocardial infarction
  • Or active hepatitis

What is involved

  • Medical history review
  • Weight
  • Physical examination
  • Periodic vital signs (body temperature
  • Heart rate
  • Respiratory rate
  • Blood pressure)
  • 12-Lead ECG
  • CT scan or MRI
  • ECHO or MUGA
  • Eye exams
  • Tumor biopsy (part B only)

Compensation

None

Contact Information

Study Coordinator
Patricia Smith, RN
Email
[email protected]
Phone
-4416
Principal Investigator
Rhonda Bitting, MD

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