A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer
A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-8M4 Given as Monotherapy in Subjects With Advanced Ovarian Cancer
1 other identifier
interventional
18
1 country
3
Brief Summary
This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 1, 2009
CompletedFirst Posted
Study publicly available on registry
January 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFebruary 27, 2013
November 1, 2010
1.7 years
January 1, 2009
February 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of adverse events
Throughout the treatment
Assessment of PK variables
Weeks 1-3, week 5, week 7 week 11, every 2 weeks during extension period, 2 and 3 months after last dose
Secondary Outcomes (3)
Incidence of anti-AGS-8M4 antibody formation
Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose
Changes in tumor status per RECIST
Week 9, and every 8 weeks during the extended treatment period
Changes in CA-125 levels
Week 9, and every 8 weeks during the extended treatment period
Study Arms (4)
1. AGS-8M4 Dose 1
EXPERIMENTAL2. AGS-8M4 Dose 2
EXPERIMENTAL3. AGS-8M4 Dose 3
EXPERIMENTAL4. AGS-8M4 Dose 4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- Subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or nonmeasureable disease after first line therapy) or progressive disease at anytime
You may not qualify if:
- No epithelial ovarian tumors of low malignant potential
- Active infection requiring treatment with systemic anti-infectives within 72 hours of screening
- Use of any investigational drug within 30 days prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
- Prior monoclonal antibody therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Agensys, Inc.collaborator
Study Sites (3)
Unknown Facility
Baltimore, Maryland, 19111, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Agensys, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2009
First Posted
January 5, 2009
Study Start
October 1, 2008
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
February 27, 2013
Record last verified: 2010-11