A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
This study has been terminated.
(Efficacy not evident in this population.)
Sponsor:
Genentech
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00543712
First received: October 12, 2007
Last updated: October 6, 2009
Last verified: October 2009
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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:
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
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
Investigators
| Study Director: | Sandra Skettino, M.D. | Genentech |
More Information
No publications provided
| Responsible Party: | Clinical Trials Posting Group, Genentech, Inc. |
| ClinicalTrials.gov Identifier: | NCT00543712 History of Changes |
| Other Study ID Numbers: | APM4171g |
| Study First Received: | October 12, 2007 |
| Last Updated: | October 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genentech:
|
Sarcoma synovial sarcoma APM4171g |
Additional relevant MeSH terms:
|
Chondrosarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma |
ClinicalTrials.gov processed this record on May 23, 2013