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

Phase 2

Terminated

Conditions: Chondrosarcoma

Interventions: Drug: PRO95780

Registration Number: NCT00543712

Lead Sponsor: Genentech, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 15

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRO95780	PRO95780	-

Primary Outcome Measures

Name	Time	Method
Adverse events
Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
Objective response

Secondary Outcome Measures

Name	Time	Method
Duration of objective response
Progression-free survival
Overall survival
Pharmacokinetic parameters

Trial Locations

Locations (4): Sarcoma Oncology Center
🇺🇸
Santa Monica, California, United States
Peter MacCallum Cancer Centre
🇦🇺
Melbourne, Australia
Dana Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States