A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00816764
First received: January 1, 2009
Last updated: February 26, 2013
Last verified: November 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
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, and every 8 weeks during the extended treatment period ] [ Designated as safety issue: No ]
- Changes in CA-125 levels [ Time Frame: Week 9, and every 8 weeks during the extended treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | October 2008 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. AGS-8M4 Dose 1 |
Biological: AGS-8M4
IV Infusion
|
| Experimental: 2. AGS-8M4 Dose 2 |
Biological: AGS-8M4
IV Infusion
|
| Experimental: 3. AGS-8M4 Dose 3 |
Biological: AGS-8M4
IV Infusion
|
| Experimental: 4. AGS-8M4 Dose 4 |
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 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| 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
Locations
| United States, Maryland | |
| Baltimore, Maryland, United States, 19111 | |
| United States, New York | |
| New York, New York, United States, 10021 | |
| 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
Additional Information:
No publications provided
| Responsible Party: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00816764 History of Changes |
| Other Study ID Numbers: | 2008001 |
| Study First Received: | January 1, 2009 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
clinical trial, phase 1 carcinoma pharmacokinetics safety ovarian |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Ovarian Neoplasms Ovarian Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Endocrine Gland Neoplasms |
Neoplasms by Site Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on June 18, 2013