Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

— PEG  

Official title:

Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Given Intravenously to Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834704
• Other study ID #: HALO-109-101
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2009
• Last updated: March 24, 2013
• Start date: February 2009
• Est. completion date: November 2012

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

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Premiere Oncology	Santa Monica	California
United States	T Gen Clinical Research Services	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	To determine the recommended phase 2 dose (RP2D) of PEGPH20. To evaluate the safety and tolerability of PEGPH20 in advanced cancer patients over a range of doses.		28 days	Yes
Secondary	To determine the pharmacokinetics (PK) of PEGPH20		28 days	Yes
Secondary	To determine the dose-limiting toxicities (DLTs) of PEGPH20.		28 days	Yes
Secondary	To observe patients for any evidence of anti-tumor activity (efficacy).		28 days	Yes
Secondary	To explore pharmacodynamic endpoints that may guide the further development of PEGPH20.		28 days	Yes