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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chondrosarcoma

Intervention / Treatment
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* Drug: PRO95780


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRO95780<br> | Drug: PRO95780<br>* Intravenous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations |  |  | 
| Objective response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of objective response |  |  | 
| Progression-free survival |  |  | 
| Overall survival |  |  | 
| Pharmacokinetic parameters |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcoma, synovial sarcoma, APM4171g