A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
Primary Purpose
Chondrosarcoma
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PRO95780
Sponsored by
About this trial
This is an interventional treatment trial for Chondrosarcoma focused on measuring Sarcoma, synovial sarcoma, APM4171g
Eligibility 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
Sites / Locations
- Sarcoma Oncology Center
- Dana Farber Cancer Institute
- MD Anderson Cancer Center
- Peter MacCallum Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PRO95780
Arm Description
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543712
Brief Title
A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
Official Title
A Phase II, Open-Label, Multicenter Study of the Efficacy and Safety of Single-Agent PRO95780 in Patients With Advanced Chondrosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Efficacy not evident in this population.
Study Start Date
May 31, 2007 (Actual)
Primary Completion Date
May 5, 2008 (Actual)
Study Completion Date
May 5, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chondrosarcoma
Keywords
Sarcoma, synovial sarcoma, APM4171g
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRO95780
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PRO95780
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Adverse events
Title
Change in vital signs before and after PRO95780 infusions; clinical laboratory evaluations
Title
Objective response
Secondary Outcome Measure Information:
Title
Duration of objective response
Title
Progression-free survival
Title
Overall survival
Title
Pharmacokinetic parameters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Skettino, M.D.
Organizational Affiliation
Genentech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
ZIP/Postal Code
3002
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Study of PRO95780 in Patients With Advanced Chondrosarcoma (APM4171g)
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