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A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer

This study has been terminated.
(Trial was terminated to allow sponsors to evaluate the future development of the drug program)
Sponsor:
Collaborator:
Agensys, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01016054
First received: November 16, 2009
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma
Ovarian Cancer
Ovarian Diseases
Ovarian Neoplasms
 Biological: AGS-8M4
Drug: Pegylated liposomal doxorubicin (PLD)
Drug: gemcitabine
Drug: carboplatin
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

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 ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Changes in tumor status per RECIST [ Time Frame: Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A. PLD plus AGS-8M4
Women with platinum resistent ovarian cancer
 Biological: AGS-8M4
IV infusion
Drug: Pegylated liposomal doxorubicin (PLD)
IV infusion
Experimental: B. Carboplatin and gemcitabine plus AGS-8M4
Women with platinum sensitive ovarian cancer
 Biological: AGS-8M4
IV infusion
Drug: gemcitabine
IV infusion
Drug: carboplatin
IV infusion

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.

  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 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016054

Locations
United States, California
Duarte, California, United States, 91010
Sponsors and Collaborators
Astellas Pharma Inc
Agensys, Inc.
Investigators
Study Director: Use Central Contact Agensys, Inc.
  More Information

Additional Information:
Link to results on JAPIC  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01016054     History of Changes
Other Study ID Numbers: 2009001
Study First Received: November 16, 2009
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Clinical Trial, Phase1
Combination Drug Therapy
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
Doxorubicin
 Gemcitabine
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013