Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Halozyme Therapeutics
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01170897
First received: July 26, 2010
Last updated: March 24, 2013
Last verified: September 2012
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Purpose
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.
| 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: | 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 |
Resource links provided by NLM:
Further study details as provided by Halozyme Therapeutics:
Primary Outcome Measures:
- 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)
| Estimated Enrollment: | 58 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Maximally Tolerated Dose
To identify the maximally tolerated dose (MTD) of PEGPH20.
|
Drug: PEGPH20
PEGylated Recombinant Human Hyaluronidase
Other Name: PEGPH20
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170897
Locations
| United States, Arizona | |
| Ramesh K. Ramanathan M.D. | |
| Scottsdale, Arizona, United States, 85258 | |
| Mayo Clinic - Scottsdale | |
| Scottsdale, Arizona, United States, 85259 | |
| United States, California | |
| cCare - California Cancer Associatesfor Research Excellence | |
| Encinitas, California, United States, 92024 | |
| United States, Michigan | |
| Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| United States, Tennessee | |
| Jeffrey R. Infante | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
| Study Director: | Joy Zhu, M.D. | Halozyme Therapeutics |
More Information
No publications provided
| Responsible Party: | Halozyme Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01170897 History of Changes |
| Other Study ID Numbers: | HALO-109-102 |
| Study First Received: | July 26, 2010 |
| 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 Tumors |
Additional relevant MeSH terms:
|
Neoplasms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013