Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Halozyme Therapeutics Identifier:
First received: July 26, 2010
Last updated: January 27, 2014
Last verified: September 2012
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

Condition Intervention Phase
Solid Tumor
Drug: PEGPH20
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer [ Time Frame: To be evaluable for MTD determination, a patient must have completed the Cycle 1 study drug doses and the associated assessments for safety and toxicity evaluation ] [ Designated as safety issue: Yes ]
    The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)

  • Safety endpoints including assessment of both serious and non-serious AEs [ Time Frame: From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20) ] [ Designated as safety issue: Yes ]
    All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)

Enrollment: 27
Study Start Date: July 2010
Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Maximally Tolerated Dose
To identify the maximally tolerated dose (MTD) of PEGPH20.
Drug: PEGPH20
PEGylated Recombinant Human Hyaluronidase

Detailed Description:
A study of PEGylated recombinant human hyaluronidase (PEGPH20) administered on a twice weekly schedule for 28 days followed by a weekly dosing schedule in patients with advanced solid tumors who have either failed to respond to standard therapy or for whom no standard therapy exists.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written, signed, IRB-approved informed consent form.
  • Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
  • Patients must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.
  • One or more tumors measurable by RECIST criteria.
  • Karnofsky performance status ≥ 70%.
  • Ejection fraction ≥ 50%, determined by echocardiogram.
  • Life expectancy at least 3 months.
  • Age ≥ 18 years.
  • Acceptable organ function; normal hepatic, renal and hematopoietic function.
  • Negative serum or urine pregnancy test result in women of childbearing potential.

Exclusion Criteria:

  • Known brain metastasis.
  • New York Heart Association Class III or IV cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy.
  • Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.
  • Patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy.
  • Heparin therapy.
  • Known infection with HIV, hepatitis B, or hepatitis C.
  • Known allergy to hyaluronidase.
  • Women currently breast feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01170897

United States, Arizona
Ramesh K. Ramanathan M.D.
Scottsdale, Arizona, United States, 85258
Mayo Clinic - Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
cCare - California Cancer Associatesfor Research Excellence
Encinitas, California, United States, 92024
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Tennessee
Jeffrey R. Infante
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Halozyme Therapeutics
Study Director: Joy Zhu, M.D. Halozyme Therapeutics
  More Information

Responsible Party: Halozyme Therapeutics Identifier: NCT01170897     History of Changes
Other Study ID Numbers: HALO-109-102 
Study First Received: July 26, 2010
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
PEGylated Recombinant Human Hyaluronidase
Metastatic or Locally Advanced Solid Tumors processed this record on May 26, 2016