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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: PEGPH20

• Registration Number: NCT01170897
• Lead Sponsor: Halozyme Therapeutics

Brief Summary

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

Detailed Description

A study of PEGylated recombinant human hyaluronidase (PEGPH20) administered on a twice weekly schedule for 28 days followed by a weekly dosing schedule in patients with advanced solid tumors who have either failed to respond to standard therapy or for whom no standard therapy exists.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Status Verified: 2012-09
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maximally Tolerated Dose	PEGPH20	To identify the maximally tolerated dose (MTD) of PEGPH20.

Primary Outcome Measures

Name	Time	Method
Safety endpoints including assessment of both serious and non-serious AEs	From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)	All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)
Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer	To be evaluable for MTD determination, a patient must have completed the Cycle 1 study drug doses and the associated assessments for safety and toxicity evaluation	The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)

Trial Locations

Locations (5)

Ramesh K. Ramanathan M.D.; 🇺🇸 Scottsdale, Arizona, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Jeffrey R. Infante; 🇺🇸 Nashville, Tennessee, United States

cCare - California Cancer Associatesfor Research Excellence; 🇺🇸 Encinitas, California, United States

Mayo Clinic - Scottsdale; 🇺🇸 Scottsdale, Arizona, United States