Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

Halozyme

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: PEGPH20

Study type: Interventional

Funder types: Industry

Identifiers

NCT00834704

HALO-109-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

14 participants in 1 patient group

1

Other group

Description:

Dose determination

Treatment:

Drug: PEGPH20