Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors (PEG)
This study has been completed.
Sponsor:
Halozyme Therapeutics
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00834704
First received: January 29, 2009
Last updated: March 24, 2013
Last verified: September 2012
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Purpose
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumor |
Drug: PEGPH20 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Halozyme Therapeutics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the pharmacokinetics (PK) of PEGPH20 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- To determine the dose-limiting toxicities (DLTs) of PEGPH20. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- To observe patients for any evidence of anti-tumor activity (efficacy). [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- To explore pharmacodynamic endpoints that may guide the further development of PEGPH20. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 14 |
| Study Start Date: | February 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Dose determination
|
Drug: PEGPH20
PEGylated recombinant human hyaluronidase
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834704
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834704
Locations
| 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 | |
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
| Study Director: | Joy Zhu, M.D. | Halozyme Therapeutics |
More Information
| Responsible Party: | Halozyme Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00834704 History of Changes |
| Other Study ID Numbers: | HALO-109-101 |
| Study First Received: | January 29, 2009 |
| Last Updated: | March 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Halozyme Therapeutics:
|
PEGPH20 PEGylated recombinant human hyaluronidase Metastatic or locally advanced solid tumor |
ClinicalTrials.gov processed this record on September 23, 2016