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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Solid Tumor

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer

Outcome Description:

The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)

Outcome Time Frame:

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

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-109-102

NCT ID:

NCT01170897

Start Date:

July 2010

Completion Date:

June 2013

Related Keywords:

  • Solid Tumor
  • PEGPH20
  • PEGylated Recombinant Human Hyaluronidase
  • Metastatic or Locally Advanced Solid Tumors
  • Neoplasms

Name

Location

Karmanos Cancer InstituteDetroit, Michigan  48201
Mayo Clinic - ScottsdaleScottsdale, Arizona  85259
Ramesh K. Ramanathan M.D.Scottsdale, Arizona  85258
cCare - California Cancer Associatesfor Research ExcellenceEncinitas, California  92024
Jeffrey R. InfanteNashville, Tennessee  37203