Date: 2014-11-12
Type of information: Initiation of patient enrollment
phase: 1b
Announcement: initiation of patient enrollment
Company: OncoEthix (Switzerland)
Product: OTX015
Action
mechanism: Bromodomain inhibitor. This synthetic small molecule is an inhibitor of BET bromodomain proteins 2/3/4. These proteins are considered potential cancer targets, as they play a pivotal role in regulating the transcription of growth-promoting and cell cycle regulators, especially c-MYC.
Disease: advanced solid tumors (BRD-NUT Midline Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer harbouring a rearrangement ALK gene/fusion protein or KRAS mutation, Castrate-Resistant Prostate Cancer, Pancreatic Ductal Carcinoma)
Therapeutic area: Cancer - Oncology
Country: Belgium, Canada, France, Spain, Switzerland)
Trial
details: The primary objective of the Phase 1b trial is to determine the maximal tolerated dose (MTD) of OTX015 administered orally to patients with selected advanced solid tumors. In addition, the trial will assess the safety profile, characterize the pharmacokinetic parameters and determine the antitumor activity of OTX015 in selected advanced solid tumors. The trial will be performed in two parts, dose escalation and expansion. In 48 patients, dose escalation to the MTD will be evaluated in two regimens in parallel. In first regimen patients will receive oral OTX015 once daily for 21 consecutive days and, in the second regimen, they will receive it once daily on days 1 to 7 and this will be repeated every three weeks (21-day cycles; 1 week on/2 weeks off). The expansion part of the study will determine the efficacy of OTX015 in 50 patients in the five indications. (NCT02259114)
Latest
news: * On November 12, 2014, Oncoethix, a Swiss-based specialist in oncology drug development, announced that the first patient has been enrolled in an international, open-label, non-randomized, multicenter Phase 1b trial of OTX015 in advanced solid tumors. The trial will be coordinated by Dr Lillian Siu, MD, of the Princess Margaret Hospital, Toronto, Canada, who is Professor of Medicine at the University of Toronto, and Director of the Phase 1 program. The trial seeks to enrol up to 98 patients across seven centers in five countries (Belgium, Canada, France, Spain and Switzerland), including the Institut Gustave-Roussy in Paris, where Professor Jean-Charles Soria is the Principal investigator. Three patients have already been enrolled. The trial aims to determine, in a first step, the suitability of five solid tumor indications under investigation (BRD-NUT Midline Carcinoma, Triple Negative Breast Cancer, Non-Small Cell Lung Cancer harbouring a rearrangement ALK gene/fusion protein or KRAS mutation, and Castrate-Resistant Prostate Cancer and Pancreatic Ductal Carcinoma) to be progressed into the Phase 2a part of the trial.
