NP28366 - MDM2 Antagonist extension study
Research type
Research Study
Full title
A Multi-Centre, Open Label, Extension Study of RO5045337 (MDM2 antagonist) Administered Orally in Patients Treated with RO5045337 on Previous Roche Sponsored Phase 1 Cancer Studies
IRAS ID
110209
Contact name
Mark Drummond
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2012-001303-20
Research summary
This study will provide continuing MDM2 antagonist treatment to patients who have shown benefit from MDM2 antagonist treatment in previous Roche phase 1 cancer studies, and have completed all of the required study assessments for that study. Globally, the study includes patients with either solid tumours or leukaemia. Specifically, in the UK, patients from the study NP28023 will be able to be considered for entry. These patients have acute myelogenous leukaemia (AML). This study will also look at long-term safety of MDM2 antagonist treatment in these cancer patients. Approximately 40 patients from current studies could be recruited into the study globally. If the patient is assessed as eligible to enter the study following a screening visit, then patients will remain on the same MDM2 antagonist formulation, dose and number of days of treatment that they received in their original study. Patients will follow a 28 day treatment cycle (period of treatment which is repeated). This involves taking MDM2 antagonist for a set number of days followed by a number of days of rest - no MDM2 antagonist. Patients will be able to continue to receive MDM2 antagonist for as long as the study remains open, until the patient has unacceptable toxicity or the patient??s cancer progresses (worsens). The study will continue for approximately 2 years. In the UK approximately 6-8 patients could be enrolled at two participating study centres. The study is sponsored by F. Hoffman-La Roche Ltd.
REC name
Scotland A REC
REC reference
12/SS/0143
Date of REC Opinion
15 Oct 2012
REC opinion
Further Information Favourable Opinion