Solid TumorPhase 1PEGNCT00834704
Safety Study of PEGPH20 Given to Patients With Advanced Solid Tumors
A Phase 1 study testing PEGPH20 in people with Solid Tumor, run by Halozyme Therapeutics at 3 sites in United States.
Trial summary
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- PEGPH20
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2009to Nov 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Premiere Oncology
Santa Monica, California, 90404
T Gen Clinical Research Services
Scottsdale, Arizona, 85258
About this study
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
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- PEGPH20
- Keywords
- PEGPH20, PEGylated recombinant human hyaluronidase, Metastatic or locally advanced solid tumor
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGPH20Drug
PEGylated recombinant human hyaluronidase
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Dose determination Receives: Drug: PEGPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (4)
To determine the pharmacokinetics (PK) of PEGPH20
Measured: 28 days
To determine the dose-limiting toxicities (DLTs) of PEGPH20.
Measured: 28 days
To observe patients for any evidence of anti-tumor activity (efficacy).
Measured: 28 days
To explore pharmacodynamic endpoints that may guide the further development of PEGPH20.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joy Zhu, M.D., Study director, Halozyme Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00834704
- Sponsor's protocol ID
- HALO-109-101
- Acronym
- PEG
- Status last verified
- Sep 2012
- First submitted
- 29 Jan 2009
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00834704
- Acronym / sponsor ID
- PEG / HALO-109-101
- Conditions
- Solid Tumor
- Keywords
- PEGPH20, PEGylated recombinant human hyaluronidase, Metastatic or locally advanced solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: PEGPH20Dose determination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGPH20PEGylated recombinant human hyaluronidase | Drug | 1 |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2013.
Related trials for Solid Tumor
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Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
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Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
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Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy Zhu, M.D. study director
Halozyme Therapeutics
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEGPH20 in people with Solid Tumor, run by Halozyme Therapeutics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2013; AzTrials last refreshed its copy on 6 Nov 2026.