Chondrosarcoma
Conditions
Keywords
Sarcoma, synovial sarcoma, APM4171g
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.
Interventions
DRUGPRO95780
Intravenous repeating dose
Sponsors
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events | — |
| Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations | — |
| Objective response | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of objective response | — |
| Pharmacokinetic parameters | — |
| Progression-free survival | — |
| Overall survival | — |
Countries
Australia, United States
Outcome results
None listed