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A Study of Apomab in Patients With Advanced Chondrosarcoma
This study is ongoing, but not recruiting participants.
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00543712
  Purpose

This is a multicenter, open-label, Phase II trial designed to evaluate the efficacy and safety of Apomab 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: apomab
Phase II

MedlinePlus related topics: Soft Tissue Sarcoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title: A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent Apomab in Patients With Advanced Chondrosarcoma

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Objective response [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Change in vital signs before and after Apomab infusions; clinical laboratory evaluations [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of objective response [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2007
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: apomab
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00543712

Sponsors and Collaborators
Genentech
Investigators
Study Director: Sandra Skettino, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Sandra Skettino, M.D., Study Director )
Study ID Numbers: APM4171g
Study First Received: October 12, 2007
Last Updated: September 29, 2008
ClinicalTrials.gov Identifier: NCT00543712  
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Sarcoma
synovial sarcoma

Study placed in the following topic categories:
Sarcoma, Synovial
Neoplasms, Connective and Soft Tissue
Synovial sarcoma
Malignant mesenchymal tumor
Chondrosarcoma
Sarcoma
Soft tissue sarcomas

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

ClinicalTrials.gov processed this record on January 15, 2009