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

Study Description

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Brief Summary:

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

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

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Official Title:	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
Study Start Date :	February 2009
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	November 2012

Arms and Interventions

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Arm	Intervention/treatment
1; Dose determination	Drug: PEGPH20; PEGylated recombinant human hyaluronidase

Outcome Measures

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Primary Outcome Measures :

1. 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. [ Time Frame: 28 days ]

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Halozyme Therapeutics

Investigators

Study Director:	Joy Zhu, M.D.	Halozyme Therapeutics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Halozyme Therapeutics
ClinicalTrials.gov Identifier:	NCT00834704 History of Changes
Other Study ID Numbers:	HALO-109-101
First Posted:	February 3, 2009
Last Update Posted:	March 26, 2013
Last Verified:	September 2012

Keywords provided by Halozyme Therapeutics:

PEGPH20; PEGylated recombinant human hyaluronidase; Metastatic or locally advanced solid tumor