MLN1117-1501, Phase 1b/2, NSCLC treatment with Docetaxel and MLN1117
Research type
Research Study
Full title
A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
IRAS ID
181603
Contact name
Peter Schmid
Contact email
Sponsor organisation
Millemmium Pharmaceuticals, Inc
Eudract number
2014-004281-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
In this open-labelled, randomised, adaptive Phase 2 study, patients with Non-small Cell Lung Cancer (NSCLC) will be treated with two drugs called MLN1117 and docetaxel. These shall either be taken together at the same time (“in combination”) or only docetaxel will be given. The study will look at the effectiveness of the combination treatment (MLN1117 and docetaxel) versus docetaxel as a stand-alone treatment.
Docetaxel is a commonly used chemotherapeutic agent that is approved by the United States Food and Drug Administration (FDA)and in Europe, for treatment of NSCLC patients. MLN1117 is an investigational agent that has not received any regulatory approval. MLN1117 in combination with docetaxel has shown anti-cancer activity in laboratory studies but has not been evaluated in NSCLC patients.
The study consists of two phases, a 1b Phase, to find the safest and most effective dose, and a second phase (Phase 2), to investigate the effectiveness of the study drug further. The study is randomised, which means that participants in the Phase 2 portion of the study will EITHER receive a combination of MLN1117 and docetaxel or docetaxel alone and will be randomly assigned to one of the two treatment groups. The study is open-labelled which means that both the participant and the researchers will be aware of which treatment the participant is receiving.
Approximately 15 participants shall be enrolled into the Phase 1b portion and between 60 - 140 participants shall be enrolled into the Phase 2 portion. The UK will only be taking part in the Phase 2 portion.
REC name
London - South East Research Ethics Committee
REC reference
15/LO/1102
Date of REC Opinion
25 Aug 2015
REC opinion
Further Information Favourable Opinion