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

Sponsors and Collaborators:	Astellas Pharma Inc Agensys, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00816764

Purpose

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.

Condition	Intervention	Phase
Carcinoma Ovarian Cancer Ovarian Diseases Ovarian Neoplasms	Biological: AGS-8M4	Phase I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Incidence of adverse events [ Time Frame: Throughout the treatment ] [ Designated as safety issue: No ]
Assessment of PK variables [ Time Frame: Weeks 1-3, week 5, week 7 week 11, every 2 weeks during extension period, 2 and 3 months after last dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of anti-AGS-8M4 antibody formation [ Time Frame: Week 1, week 7, week 11, week 15 (extension only), 2 and 3 months after last dose ] [ Designated as safety issue: No ]
Changes in tumor status per RECIST [ Time Frame: Week 9, week 17 (extension only) ] [ Designated as safety issue: No ]
Changes in CA-125 levels [ Time Frame: Week 9, week 17 (extension only) ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1. AGS-8M4 Dose 1: Experimental	Biological: AGS-8M4 IV Infusion
2. AGS-8M4 Dose 2: Experimental	Biological: AGS-8M4 IV Infusion
3. AGS-8M4 Dose 3: Experimental	Biological: AGS-8M4 IV Infusion
4. AGS-8M4 Dose 4: Experimental	Biological: AGS-8M4 IV Infusion

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 receive 4 additional doses of AGS-8M4 during the extended treatment period at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-8M4. For subjects that continue dosing, a disease assessments will be performed 2 weeks after their last dose (i.e., Week 17). A safety follow-up visit will occur 4 weeks after the last infusion of AGS-8M4.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816764

Contacts

Contact: Agensys Clinical Research & Development

310-820-8029

Clinical@agensys.com

Locations

United States, Maryland
	Recruiting
Baltimore, Maryland, United States, 19111
United States, New York
	Recruiting
New York, New York, United States, 10021
	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

Astellas Pharma Inc

Agensys, Inc.

Investigators

Study Director:

Use Central Contact

Agensys, Inc.

More Information

No publications provided

Responsible Party:	Agensys Inc. ( VP, Clinical Research and Development )
Study ID Numbers:	2008001
Study First Received:	January 1, 2009
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00816764 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

clinical trial, phase 1
carcinoma
pharmacokinetics
safety
ovarian

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer
Endocrine System Diseases

Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Ovarian Neoplasms
Neoplasms by Histologic Type
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Carcinoma
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009