Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors (PEG)
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ClinicalTrials.gov Identifier: NCT00834704 |
Recruitment Status :
Completed
First Posted : February 3, 2009
Last Update Posted : March 26, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumor | Drug: PEGPH20 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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 |
Study Start Date : | February 2009 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
1
Dose determination
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Drug: PEGPH20
PEGylated recombinant human hyaluronidase |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00834704
United States, Arizona | |
T Gen Clinical Research Services | |
Scottsdale, Arizona, United States, 85258 | |
United States, California | |
Premiere Oncology | |
Santa Monica, California, United States, 90404 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 |
Study Director: | Joy Zhu, M.D. | Halozyme Therapeutics |
Responsible Party: | Halozyme Therapeutics |
ClinicalTrials.gov Identifier: | NCT00834704 |
Other Study ID Numbers: |
HALO-109-101 |
First Posted: | February 3, 2009 Key Record Dates |
Last Update Posted: | March 26, 2013 |
Last Verified: | September 2012 |
PEGPH20 PEGylated recombinant human hyaluronidase Metastatic or locally advanced solid tumor |
Neoplasms |