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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170897
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Halozyme Therapeutics

Brief Summary:
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: PEGPH20 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Maximally Tolerated Dose
To identify the maximally tolerated dose (MTD) of PEGPH20.
Drug: PEGPH20
PEGylated Recombinant Human Hyaluronidase

Primary Outcome Measures :
  1. 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 ]
    The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)

  2. 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) ]
    All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Halozyme Therapeutics Identifier: NCT01170897     History of Changes
Other Study ID Numbers: HALO-109-102
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: September 2012

Keywords provided by Halozyme Therapeutics:
PEGylated Recombinant Human Hyaluronidase
Metastatic or Locally Advanced Solid Tumors

Additional relevant MeSH terms:
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action