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 | 52 |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, PFS, OS, evaluated per RECIST |
Biomarkers | Exploratory: RAS, BRAF, p-ERK/ERK protein |
Efficacy | ORR: 15.4% (1CR, 7PR, n=52) |
Clinically Significant Adverse Events | Serious AE: cardiac (2%), pulmonary (2%) |
Conclusion | 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 |
Reference | 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 |