ME-344 plus topotecan in patients with solid tumour cancers
Research type
Research Study
Full title
A Phase Ib Open Label Study of the Safety and Tolerability of ME-344 Given in Combination with Topotecan (Hycamtin®) in Patients with Solid Tumors
IRAS ID
158859
Contact name
Hani Gabra
Sponsor organisation
MEI Pharma, Inc.
Eudract number
2014-002551-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 16 days
Research summary
This is a Phase Ib open label study of ME-344 in patients with any confirmed locally advanced or metastatic cancer for which topotecan is a therapeutic option (small cell lung, ovarian and cervical cancers). The primary objective of this study is to determine the safety and tolerability of ME-344 when given in combination with topotecan in patients with solid tumours. The study will be conducted in 2 parts.
In Part 1 approximately 30 patients received treatment with ME-344 and topotecan and confirmed the combination was safe to proceed to Part 2.
Part 2: Subjects will receive ME-344 intravenously (i.v.) at 10 mg/kg on Days 1, 8, 15, and 22 of each 28 day cycle, in combination with topotecan 4 mg/m2 weekly on Days 1, 8 and 15 of each 28-day cycle. Up to 40 patients with either relapsed ovarian or small cell lung cancer will be enrolled to further evaluate the safety of the combination.
Patients will be allowed to continue receiving ME-344 infusions weekly in combination with topotecan according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/1728
Date of REC Opinion
27 Oct 2014
REC opinion
Further Information Favourable Opinion