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

Solid Tumor Clinical Trial

Official title:

A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170897
• Other study ID #: HALO-109-102
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2010
• Last updated: January 27, 2014
• Start date: July 2010
• Est. completion date: January 2014

Study information

• Verified date: September 2012
• Source: Halozyme Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• PEGPH20
PEGylated Recombinant Human Hyaluronidase

Locations

Country	Name	City	State
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	cCare - California Cancer Associatesfor Research Excellence	Encinitas	California
United States	Jeffrey R. Infante	Nashville	Tennessee
United States	Mayo Clinic - Scottsdale	Scottsdale	Arizona
United States	Ramesh K. Ramanathan M.D.	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Halozyme Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer	The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)	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	Yes
Primary	Safety endpoints including assessment of both serious and non-serious AEs	All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)	From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)	Yes