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

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

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

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: PEGPH20

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
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic - Scottsdale
    • Scottsdale, Arizona, United States, 85258
      • Ramesh K. Ramanathan M.D.
  • California
    • Encinitas, California, United States, 92024
      • cCare - California Cancer Associatesfor Research Excellence
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Jeffrey R. Infante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer	The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)	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
Safety endpoints including assessment of both serious and non-serious AEs	All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)	From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)

Collaborators and Investigators

• Sponsor: Halozyme Therapeutics
• Investigators: Study Director: Joy Zhu, M.D., Halozyme Therapeutics

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 26, 2010
• First Submitted That Met QC Criteria: July 26, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): January 29, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: PEGPH20; Metastatic or Locally Advanced Solid Tumors; PEGylated Recombinant Human Hyaluronidase
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HALO-109-102