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Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors (PEG)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00834704
First Posted: February 3, 2009
Last Update Posted: March 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Halozyme Therapeutics
January 29, 2009
February 3, 2009
March 26, 2013
February 2009
June 2012   (Final data collection date for primary 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. [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00834704 on ClinicalTrials.gov Archive Site
  • To determine the pharmacokinetics (PK) of PEGPH20 [ Time Frame: 28 days ]
  • To determine the dose-limiting toxicities (DLTs) of PEGPH20. [ Time Frame: 28 days ]
  • To observe patients for any evidence of anti-tumor activity (efficacy). [ Time Frame: 28 days ]
  • To explore pharmacodynamic endpoints that may guide the further development of PEGPH20. [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
 
Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors
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
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Solid Tumor
Drug: PEGPH20
PEGylated recombinant human hyaluronidase
1
Dose determination
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
14
November 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00834704
HALO-109-101
No
Not Provided
Not Provided
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