Irvalec® in Metastatic or Advanced Gastric/Esophageal cancer v. 1.0
Research type
Research Study
Full title
Phase Ib/II, Multicenter, Open-Label, Randomized, Clinical Study with Dose Optimization of Two Different Schedules of Elisidepsin Trifluoroacetate (Irvalec®) as a Single Agent in Patients with Unresectable, Locally Advanced or Metastatic Esophageal, Esophagogastric Junction or Gastric Cancer After Failure of One but not More than Two Prior Lines of Systemic Therapy
IRAS ID
56742
Contact name
Thomas Ronald Jeffry Evans
Contact email
Sponsor organisation
PharmaMar S.A.
Eudract number
2010-020325-40
Research summary
This is a multi-centre, randomised, 2-arm study to determine the optimal dose and the anti-cancer activity of a novel anti-cancer drug, elisidepsin, in patients with advanced gastric (stomach), oesophageal (gullet) or gastro-oesophageal junction cancer who have progressed after at least one (but not more than two) previous chemotherapy regimens. Approximately 116 patients will be included in the study. The trial will consist of two stages: In a Dose Optimization (Phase Ib) stage, the dose of elisidepsin will be optimized for each treatment arm in order to assess the safety and feasibility of each schedule. Once an optimal dose has been defined for each treatment arm, the Expansion (Phase II) stage will follow. In this stage, 15 patients per treatment arm will be treated at the optimal dose(s) previously defined. If at least two patients in any arm meet the primary efficacy endpoint (i.e., tumor control) and no more than four patients experience a dose limiting toxicity during the first four weeks of treatment, then accrual into that specific arm will increase to a maximum of 40 patients (25 patients to be added per arm).
REC name
West of Scotland REC 1
REC reference
10/S0703/63
Date of REC Opinion
2 Nov 2010
REC opinion
Further Information Favourable Opinion