Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors (PEG)

Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Given Intravenously to Patients With Advanced Solid Tumors

Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.

Study Overview

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

Detailed Description

This is a study of PEGPH20 in human subjects and is designed to evaluate the safety of PEGPH20 and to determine the maximum tolerated dose of PEGPH20. All patients will receive PEGPH20. Each group of patients will receive a higher dose than the previous group. This will continue until the group with the highest planned dose completes the study or until a group has major side effects from their assigned dose.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • T Gen Clinical Research Services
  • California
    • Santa Monica, California, United States, 90404
      • Premiere Oncology
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute

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:

• Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.
• Patients who have experienced disease progression after receiving appropriate standard / approved chemotherapy and for whom no further standard or palliative treatment measures exist, or who have chosen to decline standard or palliative treatment.
• One or more tumors measurable by RECIST criteria.
• Karnofsky performance status ≥ 70%.
• Recovery from any toxic or other effects of all previous therapy, including radiation, chemotherapy and surgery.
• Negative serum or urine pregnancy test result in women of childbearing potential.
• For men and women of child-producing potential, agreement to use effective contraception (hormonal or barrier birth control or abstinence) from the time of screening before study entry and throughout study participation.

Exclusion Criteria:

• Brain metastasis.
• New York Heart Association Class III or IV cardiac disease, myocardial infarction, or cardiac arrhythmia requiring medical therapy.
• Known allergy to hyaluronidase.
• Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions including psychiatric illness) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
• Women currently breast feeding.
• Concurrent participation in any other interventional therapeutic study.

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: 1; Dose determination	Drug: PEGPH20; PEGylated recombinant human hyaluronidase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the recommended phase 2 dose (RP2D) of PEGPH20. To evaluate the safety and tolerability of PEGPH20 in advanced cancer patients over a range of doses.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine the pharmacokinetics (PK) of PEGPH20	28 days
To determine the dose-limiting toxicities (DLTs) of PEGPH20.	28 days
To observe patients for any evidence of anti-tumor activity (efficacy).	28 days
To explore pharmacodynamic endpoints that may guide the further development of PEGPH20.	28 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 29, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 3, 2009

Study Record Updates

• Last Update Posted (Estimate): March 26, 2013
• Last Update Submitted That Met QC Criteria: March 24, 2013
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: PEGPH20; PEGylated recombinant human hyaluronidase; Metastatic or locally advanced solid tumor
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HALO-109-101