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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543712
Recruitment Status : Terminated (Efficacy not evident in this population.)
First Posted : October 15, 2007
Last Update Posted : June 27, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chondrosarcoma Drug: PRO95780 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma
Study Start Date : June 2007
Actual Primary Completion Date : May 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: PRO95780
    Intravenous repeating dose

Primary Outcome Measures :
  1. Adverse events
  2. Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
  3. Objective response

Secondary Outcome Measures :
  1. Duration of objective response
  2. Progression-free survival
  3. Overall survival
  4. Pharmacokinetic parameters

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543712

United States, California
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Peter MacCallum Cancer Centre
Melbourne, Australia, 3002
Sponsors and Collaborators
Genentech, Inc.
Study Director: Sandra Skettino, M.D. Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT00543712     History of Changes
Other Study ID Numbers: APM4171g
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: June 27, 2013
Last Verified: June 2013

Keywords provided by Genentech, Inc.:
synovial sarcoma

Additional relevant MeSH terms:
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type