Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

• Sponsor: Halozyme Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00834704
• Collaborator: (none)
• Enrollment: 14
• Locations: 3
• Arm: 1
• Duration (Months): 45
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

• Study Type: Interventional
• 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: Feb 1, 2009
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

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

Outcome Measures

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. [28 days]

Secondary Outcome Measures

1. To determine the pharmacokinetics (PK) of PEGPH20 [28 days]

2. To determine the dose-limiting toxicities (DLTs) of PEGPH20. [28 days]

3. To observe patients for any evidence of anti-tumor activity (efficacy). [28 days]

4. To explore pharmacodynamic endpoints that may guide the further development of PEGPH20. [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	T Gen Clinical Research Services	Scottsdale	Arizona	United States	85258
2	Premiere Oncology	Santa Monica	California	United States	90404
3	Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Halozyme Therapeutics

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Halozyme Therapeutics
• ClinicalTrials.gov Identifier: NCT00834704
• Other Study ID Numbers: HALO-109-101
• First Posted: Feb 3, 2009
• Last Update Posted: Mar 26, 2013
• Last Verified: Sep 1, 2012

• Keywords provided by Halozyme Therapeutics: PEGPH20; PEGylated recombinant human hyaluronidase; Metastatic or locally advanced solid tumor
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Mar 26, 2013