A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816764
• Other study ID #: 2008001
• Status: Completed
• Phase: Phase 1
• First received: January 1, 2009
• Last updated: February 26, 2013
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: November 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Ovarian Cancer
• Ovarian Diseases
• Ovarian Neoplasms

Intervention

Biological:
• AGS-8M4
IV Infusion

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Agensys, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Throughout the treatment	No
Primary	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	No
Secondary	Incidence of anti-AGS-8M4 antibody formation		Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose	No
Secondary	Changes in tumor status per RECIST		Week 9, and every 8 weeks during the extended treatment period	No
Secondary	Changes in CA-125 levels		Week 9, and every 8 weeks during the extended treatment period	No

External Links

•   Link to results on JAPIC