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

NCT ID: NCT00543712

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-05-05

Brief 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.

Conditions

Chondrosarcoma

Keywords

Sarcoma; synovial sarcoma; APM4171g

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Study Groups

PRO95780

Group Type: EXPERIMENTAL

PRO95780

Intervention Type: DRUG

Intravenous repeating dose

Interventions

PRO95780

Intravenous repeating dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Skettino, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

Sarcoma Oncology Center

Santa Monica, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

MD Anderson Cancer Center

Houston, Texas, United States

Peter MacCallum Cancer Centre

Melbourne, , Australia

Countries

United States; Australia

Other Identifiers

APM4171g

Identifier Type: -

Identifier Source: org_study_id