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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01170897
First received: July 26, 2010
Last updated: January 27, 2014
Last verified: September 2012

July 26, 2010
January 27, 2014
July 2010
October 2013   (final data collection date for primary outcome measure)
  • Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer [ 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 ] [ Designated as safety issue: Yes ]
    The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)
  • Safety endpoints including assessment of both serious and non-serious AEs [ Time Frame: From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20) ] [ Designated as safety issue: Yes ]
    All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)
Maximally Tolerated Dose with Incidence of Adverse Events [ Time Frame: Activity from Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after the last dose) ] [ Designated as safety issue: Yes ]
  • To identify the maximally tolerated dose (MTD) of PEGPH20 when given twice a week for 28 days. This is followed by a weekly administration schedule.
  • To determine the incidence of adverse events and clinical laboratory abnormalities defined as dose limiting toxicities in patients treated with PEGPH20.
Complete list of historical versions of study NCT01170897 on ClinicalTrials.gov Archive Site
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Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
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

This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in 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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Solid Tumor
Drug: PEGPH20
PEGylated Recombinant Human Hyaluronidase
Other Name: PEGPH20
Maximally Tolerated Dose
To identify the maximally tolerated dose (MTD) of PEGPH20.
Intervention: Drug: PEGPH20
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
January 2014
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01170897
HALO-109-102
No
Halozyme Therapeutics
Halozyme Therapeutics
Not Provided
Study Director: Joy Zhu, M.D. Halozyme Therapeutics
Halozyme Therapeutics
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP