Clinical trial NCT00816764: A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma
Ovarian Cancer
Ovarian Diseases
Ovarian Neoplasms
Keywords: clinical trial, phase 1
carcinoma
pharmacokinetics
safety
ovarian
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Agensys, Inc.
First posted: 2009-01-05
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Throughout the treatment
measure: Assessment of PK variables
timeFrame: Weeks 1-3, week 5, week 7 week 11, every 2 weeks during extension period, 2 and 3 months after last dose
Secondary outcomes:
measure: Incidence of anti-AGS-8M4 antibody formation
timeFrame: Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose
measure: Changes in tumor status per RECIST
timeFrame: Week 9, and every 8 weeks during the extended treatment period
measure: Changes in CA-125 levels
timeFrame: Week 9, and every 8 weeks during the extended treatment period
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
Study officials:
affiliation: Agensys, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References: