A Phase 1b/2, Study of Pegylated Recombinant Human Hyaluronidase Combined With Docetaxel Versus Docetaxel Alone in Subjects With Recurrent Previously Treated Locally Advanced or Metastatic NSCLC.

Description

A Phase 1b/2 study for patients with Stage IIIB/IV NSCLC to participate in one of three portions of this study. The first portion is dose escalation in which subjects are tested with PEGPH20 at various doses (1.6, 3.0, 4.0, 5.3 and 7.0 ug/kg) and dosing schedules (either once every 21 day cycle or twice/week or 6 times/21 day cycle) plus a standard dose of docetaxel (75mg/m2 once every 3 weeks) until the MTD (maximum tolerated dose) is reached in both dosing schedules. The second portion is a randomized schedule finding component in which the MTDs of both dosing schedules are tested (approximately 25-30 subjects) and the most safe, efficacious and tolerated dose/schedule is chosen to be tested in the Phase 2 portion. Phase 2 will compare the selected dose schedule of PEGPH20 plus docetaxel with docetaxel alone.

Study Start Date

December 2014

Estimated Completion Date

February 2018

Interventions

  • Drug: Docetaxel
  • Drug: PEGPH20

Specialties

  • Oncology: Lung/Thoracic Oncology
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Carcinoma
  • Lung Neoplasms
  • PEGPH20

Study ID

Halozyme Therapeutics -- HALO-107-201

Status

Unknown

Trial ID

NCT02346370

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

238

Sponsor

Halozyme Therapeutics

Inclusion Criteria

  • Signed, approved Informed Consent
  • Histologically confirmed and previously treated Stage IIIB/IV NSCLC, having failed no more than 1 platinum chemo regimen
  • Available archival tumor tissue block
  • 10 unstained, core biopsy slides that meet specific tissue requirements
  • Phase 1b Schedule finding/Phase 2
  • one or more tumors measureable on CT scan (RECIST 1.1)
  • Life expectancy
  • =/> 3 months, ECOG (Eastern Cooperative Oncology Group) status = 0 or 1
  • Negative pregnancy test
  • Men and women agreement to use effective contraceptive method
  • Specific ranges/levels of Screening labs that are acceptable

Exclusion Criteria

  • Previous treatment with docetaxel
  • New York Heart Assoc Class III or IV cardiac disease, myocardial infarction within the past 12
  • months
  • Prior history of cerebrovascular accident or transient ischemic attack or preexisting
  • carotid artery disease
  • History of pulmonary embolism or pulmonary embolism found on screening exam
  • Active, uncontrolled bacterial, viral or fungal infection at time of screening
  • Known infection with HIV, Hepatitis B or C
  • Known allergy to hyaluronidase or any constituents of docetaxel formulation
  • Current use (within 10 days of day 1) of megestrol acetate
  • Women currently pregnant or breast feeding
  • Intolerance to dexamethasone as determined by Investigator
  • History of another primary cancer within the last 3 years
  • Any other disease, metabolic dysfunction, physical exam finding or clinical lab finding that leads to reasonable suspicion of disease that contraindicates the use of an investigational drug that might affect interpretation of results or render subject at high risk for treatment complications
  • In opinion of Investigator, make subject unsuitable for study. Subject's inability to comply with study and follow-up procedures, as judged by the Investigator

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (11)

Study Location Distance Name Phone Email
DartmouthHitchcock Medical Center - Lebanon, New Hampshire 105.5 miles None None None
Penn State Milton S Hershey Medical Center - Hershey, Pennsylvania 321.7 miles None None None
University of Rochester - Rochester, New York 335.8 miles None None None
University Hospitals of Cleveland - Cleveland, Ohio 544.0 miles None None None
Levine Cancer Institute - Charlotte, North Carolina 723.9 miles None None None
Tennessee Cancer Specialists - Knoxville, Tennessee 822.5 miles None None None
Norton Cancer Institute - Louisville, Kentucky 823.2 miles None None None
California Cancer Associates for Research and Excellence cCare - Encinitas, California 2,577.4 miles None None None
Moores UCSD Cancer Center Clinical Trials Office - San Diego, California 2,581.5 miles None None None
California Cancer Associates for Research and Excellence cCare - Fresno, California 2,589.0 miles None None None
Pacific Hematology Oncology Associates - San Francisco, California 2,698.0 miles D None None

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