Solid TumorPhase 1NCT01170897
Study of PEGPH20 With Initial Dexamethasone Premedication Given Intravenously to Patients With Advanced Solid Tumors
A Phase 1 study testing PEGPH20 in people with Solid Tumor, run by Halozyme Therapeutics at 5 sites in United States.
Trial summary
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors. 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
- 27 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2010to Jan 2014
- 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
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Karmanos Cancer Institute
Detroit, Michigan, 48201
cCare - California Cancer Associatesfor Research Excellence
Encinitas, California, 92024
Jeffrey R. Infante
Nashville, Tennessee, 37203
Ramesh K. Ramanathan M.D.
Scottsdale, Arizona, 85258
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259
About this study
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
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.
Read the 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.
- Conditions
- Solid Tumor
- Being tested
- PEGPH20
- Keywords
- PEGPH20, PEGylated Recombinant Human Hyaluronidase, Metastatic or Locally Advanced Solid Tumors
- 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 |
|---|---|---|
| Maximally Tolerated Dose | Other | To identify the maximally tolerated dose (MTD) of PEGPH20. Receives: Drug: PEGPH20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally Tolerated Dose (MTD) of PEGPH20 when given to patients with cancer
The PEGPH20 monotherapy MTD is the highest dose at which no more than one of six evaluable patients experience Dose-Limiting Toxicity (DLT)
Measured: 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
Safety endpoints including assessment of both serious and non-serious AEs
All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)
Measured: From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2013
- Study completionJan 2014
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
- 27 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
- NCT01170897
- Sponsor's protocol ID
- HALO-109-102
- Status last verified
- Sep 2012
- First submitted
- 26 Jul 2010
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01170897
- Acronym / sponsor ID
- HALO-109-102
- Conditions
- Solid Tumor
- Keywords
- PEGPH20, PEGylated Recombinant Human Hyaluronidase, Metastatic or Locally Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Jul 2010 (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.
This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maximally Tolerated Dose | Other | Drug: PEGPH20To identify the maximally tolerated dose (MTD) of PEGPH20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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%.
Key exclusion criteria (8 listed)
- 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.
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 | Maximally Tolerated Dose |
Primary outcome
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
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)
All safety data will be evaluated using the NCI CTCAE scoring system (version 4.0)
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 29 Jan 2014.
Related trials for Solid Tumor
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
Metastatic Malignant Solid Neoplasm, Lymphoma
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
5 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 5 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 10 inclusion and 8 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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). The study lists 2 primary outcomes in all. 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 29 Jan 2014.