A Phase Ib/IIa Study of AZD2014 in Combination With Selumetinib in Patients With Advanced Cancers (TORCMEK)

NCT02583542 Phase 1/Phase 2 UNKNOWN

Open-label, multicentre phase Ib/IIa study of AZD2014 administered with selumetinib. There are two parts to this study: a dose-escalation part in treatment-refractory advanced solid tumours and a subsequent separate expansion cohort part for TNBC, squamous cell lung cancers, non-squamous cell lung cancers with KRAS mutations and non-squamous cell lung cancers with wild-type KRAS

Details

Lead sponsor	Queen Mary University of London
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	118
Start date	2015-06
Completion	2020-03

Conditions

• Triple-Negative Breast Cancer
• Squamous Cell Lung Cancer
• Non-squamous Cell Lung Cancer With KRAS Mutations
• Non-squamous Cell Lung Cancer With Wild-type KRAS

Interventions

• AZD2014
• AZD6244

Primary outcomes

• Establish feasible dose levels and regimens of AZD2014 and selumetinib when given in combination by close observation of any dose limiting toxicities — First 21 days of treatment.
  Dose limiting toxicity is defined as occurrence of any of the following toxicities during the first 21 days of treatment: * Any grade \>3 non-haematological toxicity (excluding nausea, vomiting or diarrhoea) * Grade 3 nausea, vomiting or diarrhoea lasting \>48 hours despite supportive care or any Grade 4 hause, vomiting or diarrhoea * Grade 4 neutropenia lasting \>7days or febrile neutropenia * Grade 3 thrombocytopenia with bleeding or grade 4 thrombocytopenia * Inability to receive at least 75% of the planned doses due to unresolved toxicity * Any treatment delays for \>14 days due to unresolved toxicity NB: This primary outcome relates to the Phase Ib part of study.
• Assess clinical activity, as measured by disease control rate, of AZD2014 in combination with selumetinib. — Day 1 to > 12 weeks.
  Disease control rate is defined as number of patients with complete or partial response or stable disease maintained \>12weeks (as assessed by the site radiologist and/or investigator, using RECIST 1.1) divided by the number of patients in the analysis. Patients without a post-baseline tumour assessment will be considered to have no disease control. NB: This primary outcome relates only to the Phase IIa part of this study

Countries

United Kingdom