A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)

Chondrosarcoma Clinical Trial

Official title:

A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543712
• Other study ID #: APM4171g
• Status: Terminated
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Chondrosarcoma

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