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
18 Years
N/A
Female
Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms
Trial Information
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
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled sequentially into 1
of the 4 planned dose cohorts according to a standard dose escalation study design. A
disease assessment will be performed at study week 9 (+/- 3 days). The assessment will be
based on clinical signs and symptoms, changes in radiographic images, and changes in CA-125
levels. Subjects without evidence of disease progression may continue to receive AGS-8M4
during the extended treatment period at the dose and schedule of their assigned cohort until
disease progression intolerability of AGS-8M4 or consent withdrawal. For subjects that
continue dosing, disease assessments will be performed every 8 weeks during the extended
treatment period. A safety follow-up visit will occur 4 weeks after the last infusion of
AGS-8M4.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of adverse events
Outcome Time Frame:
Throughout the treatment
Safety Issue:
No
Principal Investigator
Use Central Contact
Investigator Role:
Study Director
Investigator Affiliation:
Agensys, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
2008001
NCT ID:
NCT00816764
Start Date:
October 2008
Completion Date:
June 2010
Related Keywords:
- Carcinoma
- Ovarian Cancer
- Ovarian Diseases
- Ovarian Neoplasms
- clinical trial, phase 1
- carcinoma
- pharmacokinetics
- safety
- ovarian
- Neoplasms
- Carcinoma
- Ovarian Neoplasms
- Ovarian Diseases
Name | Location |
|---|---|
| Albany, New York 12208 | |
| Baltimore, Maryland 21287 |
