A Phase II Trial of AZD6244 (NSC# 748727) in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Trial ID # NCT00551070
Phase II
Drug Class Signaling Pathway Inhibitors: RAS-RAF-MEK-ERK/MEK
Drug Name Selumetinib
Alternate Drug Names ARRY-142886, AZD6244, Koselugo
Drugs in Trial Selumetinib
Eligible Participant

Recurrent low-grade serous ovarian or peritoneal carcinoma

Patients Enrolled


Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, PFS, OS, evaluated per RECIST


Exploratory: RAS, BRAF, p-ERK/ERK protein


ORR: 15.4% (1CR, 7PR, n=52)
DCR: 81% (1CR, 7PR, 34SD, n=52)
PFS: 11.0 months

Clinically Significant Adverse Events

Serious AE: cardiac (2%), pulmonary (2%)
Grade 3-4 AE: gastrointestinal (26%), dermatological (18%), metabolic (14%), fatigue (12%)


Promising activity in patients with low grade serous ovarian cancer; No significant correlation of response with BRAF or RAS mutations, but analysis performed on primary tumor specimen


Farley J et al. Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study. Lancet Oncol (2013) 14(2):134-40

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