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

This study has been terminated.
(Efficacy not evident in this population.)
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00543712
First received: October 12, 2007
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Chondrosarcoma
Drug: PRO95780
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

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

Secondary Outcome Measures:
  • Duration of objective response
  • Progression-free survival
  • Overall survival
  • Pharmacokinetic parameters

Estimated Enrollment: 90
Study Start Date: June 2007
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: PRO95780
    Intravenous repeating dose
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543712

Locations
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
Australia
Peter MacCallum Cancer Centre
Melbourne, Australia, 3002
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Sandra Skettino, M.D. Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00543712     History of Changes
Other Study ID Numbers: APM4171g
Study First Received: October 12, 2007
Last Updated: June 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:
Sarcoma
synovial sarcoma
APM4171g

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

ClinicalTrials.gov processed this record on October 23, 2014