NCT01170897

Brief Summary

This is an open-label, multicenter, dose-escalation, safety, tolerability, pharmacokinetic and pharmacodynamic study in patients with advanced solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2010

Typical duration for phase_1

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

July 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 29, 2014

Status Verified

September 1, 2012

Enrollment Period

3.3 years

First QC Date

July 26, 2010

Last Update Submit

January 27, 2014

Conditions

Solid Tumor

Keywords

PEGPH20PEGylated Recombinant Human HyaluronidaseMetastatic or Locally Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    From Day 1 of Treatment Cycle 1, thru to Follow-up (within 28 days after last dose of PEGPH20)

Study Arms (1)

Maximally Tolerated Dose

OTHER

To identify the maximally tolerated dose (MTD) of PEGPH20.

Drug: PEGPH20

Interventions

PEGPH20DRUG

PEGylated Recombinant Human Hyaluronidase

Maximally Tolerated Dose

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Ramesh K. Ramanathan M.D.

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic - Scottsdale

Scottsdale, Arizona, 85259, United States

Location

cCare - California Cancer Associatesfor Research Excellence

Encinitas, California, 92024, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Jeffrey R. Infante

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

July 26, 2010

First Posted

July 27, 2010

Study Start

July 1, 2010

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

January 29, 2014

Record last verified: 2012-09

Locations

US(5)