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
18 Years
N/A
Female
Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms
Trial Information
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
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of adverse events
Outcome Time Frame:
Throughout the treatment
Safety Issue:
No
Principal Investigator
Use Central Contact
Investigator Role:
Study Director
Investigator Affiliation:
Agensys, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
2009001
NCT ID:
NCT01016054
Start Date:
October 2009
Completion Date:
April 2010
Related Keywords:
- Carcinoma
- Ovarian Cancer
- Ovarian Diseases
- Ovarian Neoplasms
- Clinical Trial, Phase1
- Combination Drug Therapy
- pharmacokinetics
- safety
- Ovarian
- Neoplasms
- Carcinoma
- Ovarian Neoplasms
- Ovarian Diseases
Name | Location |
|---|---|
| Fountain Valley, California 92708 |
