NCT00834704

Brief Summary

Open-label, multicenter, dose-escalation, safety, pharmacodynamic, and pharmacokinetic study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2009

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 26, 2013

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

January 29, 2009

Last Update Submit

March 24, 2013

Conditions

Solid Tumor

Keywords

PEGPH20PEGylated recombinant human hyaluronidaseMetastatic or locally advanced solid tumor

Outcome Measures

Primary Outcomes (1)

  • 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.

    28 days

Secondary Outcomes (4)

  • To determine the pharmacokinetics (PK) of PEGPH20

    28 days

  • To determine the dose-limiting toxicities (DLTs) of PEGPH20.

    28 days

  • To observe patients for any evidence of anti-tumor activity (efficacy).

    28 days

  • To explore pharmacodynamic endpoints that may guide the further development of PEGPH20.

    28 days

Study Arms (1)

1

OTHER

Dose determination

Drug: PEGPH20

Interventions

PEGPH20DRUG

PEGylated recombinant human hyaluronidase

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

T Gen Clinical Research Services

Scottsdale, Arizona, 85258, United States

Location

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

PEGPH20

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joy Zhu, M.D.

    Halozyme Therapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2009

First Posted

February 3, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2012

Study Completion

November 1, 2012

Last Updated

March 26, 2013

Record last verified: 2012-09

Locations

US(3)