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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170897
First Posted: July 27, 2010
Last Update Posted: January 29, 2014
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.
Information provided by (Responsible Party):
Halozyme Therapeutics
  Purpose
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
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

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 ]
    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) ]
    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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01170897


Locations
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
Investigators
Study Director: Joy Zhu, M.D. Halozyme Therapeutics
  More Information

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT01170897     History of Changes
Other Study ID Numbers: HALO-109-102
First Submitted: July 26, 2010
First Posted: July 27, 2010
Last Update Posted: January 29, 2014
Last Verified: September 2012

Keywords provided by Halozyme Therapeutics:
PEGPH20
PEGylated Recombinant Human Hyaluronidase
Metastatic or Locally Advanced Solid Tumors

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