Conditions: Advanced Solid Malignancies
Keywords: Phase I cancer advanced solid malignancies dose escalation AZD2014 mTor kinase inhibitor safety pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 172
Healthy volunteers: no

Brief summary:
The main purpose of the study is to establish a safe dose of the drug by providing information on any potential side effects this drug may cause and collecting data about how a patient's cancer responds to the drug. The study will also assess the blood levels and action of AZD2014 in the body over a period of time and will indicate whether the drug has an effect on the types of cancer the patients have.

Detailed description:

Arms:
arm 1: AZD2014 dose escalation phase in Part A and expansion phase in Part B.

Interventions: intervention 1: AZD2014
Intervention descriptions: intervention 1: Dose escalation phase: a single dose taken orally (solution or tablet) of AZD2014 on single dose day 1 (visit 2), followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or Single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal. Expansion phase: twice daily dosing from day 1 until discontinuation or withdrawal or a single dose taken orally of AZD2014 on single dose day 1 (visit 2), followed by a single dose on second single dose day 1 (visit 3) after a washout period (48 hours - 7 days) followed by once or twice daily continuous dosing after a washout period (48 hours - 7 days) at visit 4, until discontinuation or withdrawal or single or multiple doses taken orally (solution or tablet) of AZD2014 taken intermittently until discontinuation or withdrawal.

Protocol document: