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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

Phase 2
18 Years
Not Enrolling

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Trial Information

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

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

Adverse events

Principal Investigator

Sandra Skettino, M.D.

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

Related Keywords:

  • Chondrosarcoma
  • Sarcoma
  • synovial sarcoma
  • APM4171g
  • Chondrosarcoma



MD Anderson Cancer CenterHouston, Texas  77030-4096
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Sarcoma Oncology CenterSanta Monica, California  90403