A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer
Primary Purpose
Carcinoma, Ovarian Cancer, Ovarian Diseases
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AGS-8M4
Pegylated liposomal doxorubicin (PLD)
gemcitabine
carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma focused on measuring Clinical Trial, Phase1, Combination Drug Therapy, pharmacokinetics, safety, Ovarian
Eligibility Criteria
Inclusion Criteria:
- Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
- Subjects with either platinum resistant or platinum sensitive ovarian cancer
- At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
- Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)
Exclusion Criteria:
- Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
- Use of any investigational drug within 30 days prior to screening
- Prior monoclonal antibody therapy other than Avastin
- Avastin administration within 90 days of screening
- History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A. PLD plus AGS-8M4
B. Carboplatin and gemcitabine plus AGS-8M4
Arm Description
Women with platinum resistent ovarian cancer
Women with platinum sensitive ovarian cancer
Outcomes
Primary Outcome Measures
Incidence of adverse events
Secondary Outcome Measures
Assessment of PK variables
Incidence of anti-AGS-8M4 antibody formation
Changes in tumor status per RECIST
Change in CA-125 levels
Full Information
NCT ID
NCT01016054
First Posted
November 16, 2009
Last Updated
February 26, 2013
Sponsor
Astellas Pharma Inc
Collaborators
Agensys, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01016054
Brief Title
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer
Official Title
A Phase 1b, Parallel Arm, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Two Different Chemotherapy Regimens in Women With Platinum Resistant or Platinum Sensitive Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Trial was terminated to allow sponsors to evaluate the future development of the drug program
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 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
No
5. Study Description
Brief Summary
This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.
Detailed Description
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled into 1 of 2 treatment arms according to their disease status. A disease assessment will be performed every 8 or 9 weeks (± 3 days) depending on the treatment arm assignment. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may continue to receive treatment based on their original treatment assignment until disease progression or intolerability. A safety follow-up visit will occur 4 weeks after the last dose 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, Phase1, Combination Drug Therapy, pharmacokinetics, safety, Ovarian
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A. PLD plus AGS-8M4
Arm Type
Experimental
Arm Description
Women with platinum resistent ovarian cancer
Arm Title
B. Carboplatin and gemcitabine plus AGS-8M4
Arm Type
Experimental
Arm Description
Women with platinum sensitive ovarian cancer
Intervention Type
Biological
Intervention Name(s)
AGS-8M4
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Pegylated liposomal doxorubicin (PLD)
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
IV infusion
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
Throughout the treatment
Secondary Outcome Measure Information:
Title
Assessment of PK variables
Time Frame
Treatment Arm A: Weeks 1 and 3 of each cycle. Treatment Arm B: Week 1 of each cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Title
Incidence of anti-AGS-8M4 antibody formation
Time Frame
Treatment Arm A: Day 1 of every other cycle and at Day 15 for the first cycle only. Treatment Arm B: Day 1 of every other cycle. In addition, samples will be drawn at the Safety F/U, 2 Month F/U and 3 Month F/U visits.
Title
Changes in tumor status per RECIST
Time Frame
Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.
Title
Change in CA-125 levels
Time Frame
Treatment Arm A: Day 1 and Day 15 of each cycle. Treatment Arm B: Day 1 of each cycle. In addition, samples will be drawn at the Safety F/U.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
Subjects with either platinum resistant or platinum sensitive ovarian cancer
At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities
Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)
Exclusion Criteria:
Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening
Use of any investigational drug within 30 days prior to screening
Prior monoclonal antibody therapy other than Avastin
Avastin administration within 90 days of screening
History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)
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
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=533
Description
Link to results on JAPIC
Learn more about this trial
A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer
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