Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

NCT ID: NCT00834704

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-11-30

Brief Summary

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

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.

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

1

Dose determination

Group Type: OTHER

PEGPH20

Intervention Type: DRUG

PEGylated recombinant human hyaluronidase

Interventions

PEGPH20

PEGylated recombinant human hyaluronidase

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Halozyme Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joy Zhu, M.D.

Role: STUDY_DIRECTOR

Halozyme Therapeutics

Locations

T Gen Clinical Research Services

Scottsdale, Arizona, United States

Premiere Oncology

Santa Monica, California, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

HALO-109-101

Identifier Type: -

Identifier Source: org_study_id