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

NCT01016054TerminatedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Astellas Pharma Inc

Enrollment

4

Start Date

2009-10-01

Completion Date

2010-04-01

Study Type

INTERVENTIONAL

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

Interventions

AGS-8M4Pegylated liposomal doxorubicin (PLD)gemcitabinecarboplatin

Conditions

CarcinomaOvarian CancerOvarian DiseasesOvarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

Incidence of adverse events

Time frame: Throughout the treatment

Secondary Outcomes

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.

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.

Changes in tumor status per RECIST

Time frame: Treatment Arm A: Every 8 weeks. Treatment Arm B: Every 9 weeks.

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.

Locations

Duarte, United States