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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Joy Zhu, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Halozyme Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

HALO-109-101

NCT ID:

NCT00834704

Start Date:

February 2009

Completion Date:

November 2012

Related Keywords:

  • Solid Tumor
  • PEGPH20
  • PEGylated recombinant human hyaluronidase
  • Metastatic or locally advanced solid tumor
  • Neoplasms

Name

Location

Premiere Oncology Santa Monica, California  90404
Sarah Cannon Research Institute Nashville, Tennessee  37203
T Gen Clinical Research Services Scottsdale, Arizona  85258