TORCMEK
Research type
Research Study
Full title
A Phase Ib/IIa study of AZD2014 in combination with Selumetinib in patients with advanced cancers.
IRAS ID
172356
Contact name
Peter Schmid
Contact email
Eudract number
2014-002613-31
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Summary of Research
Selumetinib and AZD2014 are two new anti-cancer treatments that AstraZeneca is developing; neither are yet approved for clinical use.Selumetinib is a drug that acts by blocking a protein called MEK, which has been linked to the development and growth of multiple cancers. AZD2014 is a drug that blocks a protein called mTOR that is involved in the growth and spread of cancer. Blocking the action of either MEK or mTOR alone may slow down or stop the cancer growing. Combining both drugs may make the cancer more sensitive than if Selumetinib or AZD2014 are used alone and as such make this treatment more effective.
Although Selumetinib and AZD2014 given alone and in combination with other anti-cancer drugs have been tested in people with advanced cancer, the specific combination of Selumetinib and AZD2014 has not been used in people before. This study is being carried out to see what effects Selumetinib and AZD2014 have on cancer when given to in combination with each other. The development of the combination of Selumetinib and AZD2014 is intended to provide a new treatment option for patients with cancer.
Summary of Results
The TORCMEK safety review committee agreed that the I3C schedule (125mg BD AZD2014 2 days on/ 5 days and 75mg BD selumetinib continuous daily) was the best option to take forward to the Phase IIa part of the study.- There were overall no concerns about taking C2C (35mg BD AZD2014 continuous daily plus 75mg BD continuous daily) into a confirmatory safety Phase II study in other protocols.
- Following the decision by the IMP Manufacturer to cease development of AZD2014, recruitment into the study stopped prematurely when only 36 patients out of 94 were recruited. Efficacy data was included in the EudraCT record but drawing meaningful conclusions per disease cohort was difficult.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0404
Date of REC Opinion
27 Apr 2015
REC opinion
Further Information Favourable Opinion