Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Halozyme Therapeutics
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Written, signed, IRB-approved informed consent form.

• Pathologic (histologic or cytologic) confirmation of metastatic or locally advanced solid tumor.

• Patients must have a pathologically documented, definitively diagnosed, advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available or the patient refuses standard therapy.

• One or more tumors measurable by RECIST criteria.

• Karnofsky performance status ≥ 70%.

• Ejection fraction ≥ 50%, determined by echocardiogram.

• Life expectancy at least 3 months.

• Age ≥ 18 years.

• Acceptable organ function; normal hepatic, renal and hematopoietic function.

• Negative serum or urine pregnancy test result in women of childbearing potential.

Exclusion Criteria:

• Known brain metastasis.

• New York Heart Association Class III or IV cardiac disease, myocardial infarction within 6 months of enrollment, or cardiac arrhythmia requiring medical therapy.

• Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy.

• Patients with uncontrolled diabetes (requiring medication change within 30 days of screening), or requiring insulin therapy.

• Heparin therapy.

• Known infection with HIV, hepatitis B, or hepatitis C.

• Known allergy to hyaluronidase.

• Women currently breast feeding.