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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00543712
Other study ID # APM4171g
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 31, 2007
Est. completion date May 5, 2008

Study information

Verified date December 2022
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of PRO95780 when given as a single agent in patients with advanced chondrosarcoma. Up to 90 patients with confirmed chondrosarcoma will be enrolled.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date May 5, 2008
Est. primary completion date May 5, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ability to understand and willingness to sign a written informed consent document - Age = 18 years - Histologic diagnosis of chondrosarcoma, verifiable after enrollment - Measurable disease - Previously treated or incurable disease without options for standard of care therapy - ECOG performance status of 0-2 - Life expectancy of > 3 months - For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device [IUD], physical barrier) throughout the trial and for 1 year following their final exposure to study treatment Exclusion Criteria: - Systemic therapy or radiotherapy within 4 weeks prior to Day 1 - Prior therapy with agents targeting the DR5 apoptosis pathway - Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study - Other invasive malignancies within 5 years prior to Day 1 - Known active brain metastases - Uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring parenteral antibiotics at enrollment - Clinically significant, symptomatic cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia, Grade II or greater peripheral vascular disease, or history of major heart surgery within 6 months of Day 1, or any situation that would likely limit compliance with study requirements - Known to be positive for hepatitis C or hepatitis B surface antigen - History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications - Use of anticoagulation therapy - Participation in clinical trials or undergoing other investigational procedures within 30 days prior to Day 1 - Pregnancy or breast feeding - Known sensitivity to any of the products administered during the study - Any disorder that compromises the ability of the patient to give written informed consent and/or comply with study procedures

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PRO95780
Intravenous repeating dose

Locations

Country Name City State
Australia Peter MacCallum Cancer Centre Melbourne
United States Dana Farber Cancer Institute Boston Massachusetts
United States MD Anderson Cancer Center Houston Texas
United States Sarcoma Oncology Center Santa Monica California

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events
Primary Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
Primary Objective response
Secondary Duration of objective response
Secondary Progression-free survival
Secondary Overall survival
Secondary Pharmacokinetic parameters
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