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Clinical Trial
. 2014 Mar;132(3):526-30.
doi: 10.1016/j.ygyno.2013.12.018. Epub 2013 Dec 18.

A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study

Lainie P Martin  1 , Michael Sill  2 , Mark S Shahin  3 , Matthew Powell  4 , Paul DiSilvestro  5 , Lisa M Landrum  6 , Stephanie L Gaillard  7 , Michael J Goodheart  8 , James Hoffman  9 , Russell J Schilder  10
Affiliations
Clinical Trial

A phase II evaluation of AMG 102 (rilotumumab) in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study

Lainie P Martin et al. Gynecol Oncol. 2014 Mar.

Abstract

Objective: This open-label, multi-institutional phase II trial evaluated activity and safety of rilotumumab (AMG 102), a monoclonal antibody that targets HGF (hepatocyte growth factor), the ligand for the MET receptor, in women with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer.

Patients and methods: Women were eligible for treatment with rilotumumab if they had measurable disease, a performance status of 0, 1 or 2, previously received platinum-based therapy with a progression-free interval of <12 months or a second recurrence, and adequate bone marrow and organ function. Patients received rilotumumab 20mg/kg IV every 14 days until evidence of unacceptable toxicity or disease progression. The study utilized co-dual primary endpoints of tumor response and six-month PFS to assess the efficacy of rilotumumab. Secondary endpoints included the frequency and severity of adverse events and the duration of progression-free and overall survival.

Results: Thirty-one women enrolled and received rilotumumab. All were eligible for analysis. One patient achieved a complete response (3.2%; 90% CI 0.2-14%), and two women had 6-month PFS (6.5%; 90% CI 1.1-19%). Most adverse events were grade 1 or 2, with no grade 4 adverse events. Grade 3 adverse events were gastrointestinal (4), metabolic (3) anemia (3), a thromboembolic event (1), ventricular tachycardia (1), hypotension during infusion (1) and fatigue (1). The study was stopped after the first stage of accrual.

Conclusion: Rilotumumab was well-tolerated, but had limited activity. The level of activity does not warrant further evaluation of rilotumumab as a single agent in patients with ovarian cancer.

Keywords: AMG 102; Clinical trial; HGF; OVARIAN CANCER; Rilotumumab MET; Scatter factor.

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Conflict of interest statement

Conflict of Interest: The co-authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Kaplan-Meier progression free and overall survival curves. [28]
See this image and copyright information in PMC

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