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

Primary Purpose

Carcinoma, Ovarian Cancer, Ovarian Diseases

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

AGS-8M4

About this trial

This is an interventional treatment trial for Carcinoma focused on measuring clinical trial, phase 1, carcinoma, pharmacokinetics, safety, ovarian

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

1. AGS-8M4 Dose 1

2. AGS-8M4 Dose 2

3. AGS-8M4 Dose 3

4. AGS-8M4 Dose 4

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events

Assessment of PK variables

Secondary Outcome Measures

Incidence of anti-AGS-8M4 antibody formation

Changes in tumor status per RECIST

Changes in CA-125 levels

Full Information

NCT ID

NCT00816764

First Posted

January 1, 2009

Last Updated

February 26, 2013

Sponsor

Astellas Pharma Inc

Collaborators

Agensys, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00816764

Brief Title

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

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

Collaborators

Agensys, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms

Keywords

clinical trial, phase 1, carcinoma, pharmacokinetics, safety, ovarian

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. AGS-8M4 Dose 1

Arm Type

Experimental

Arm Title

2. AGS-8M4 Dose 2

Arm Type

Experimental

Arm Title

3. AGS-8M4 Dose 3

Arm Type

Experimental

Arm Title

4. AGS-8M4 Dose 4

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

AGS-8M4

Intervention Description

IV Infusion

Primary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

Throughout the treatment

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Changes in tumor status per RECIST

Time Frame

Week 9, and every 8 weeks during the extended treatment period

Title

Changes in CA-125 levels

Time Frame

Week 9, and every 8 weeks during the extended treatment period

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Use Central Contact

Organizational Affiliation

Agensys, Inc.

Official's Role

Study Director

Facility Information:

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

19111

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=531

Description

Link to results on JAPIC

Learn more about this trial

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

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