Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors - Full Text View

Purpose

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

Condition	Intervention	Phase
Solid Tumor	Drug: PEGPH20	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: 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

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:

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:

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


Enrollment:	14
Study Start Date:	February 2009
Study Completion Date:	November 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Dose determination	Drug: PEGPH20 PEGylated recombinant human hyaluronidase

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.

Eligibility


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834704

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


Responsible Party:	Halozyme Therapeutics
ClinicalTrials.gov Identifier:	NCT00834704 History of Changes
Other Study ID Numbers:	HALO-109-101
Study First Received:	January 29, 2009
Last Updated:	March 24, 2013

Keywords provided by Halozyme Therapeutics:


PEGPH20 PEGylated recombinant human hyaluronidase Metastatic or locally advanced solid tumor

ClinicalTrials.gov processed this record on June 22, 2017

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