study to assess the safety, tolerability, pharmacokinetics (PK) and preliminary efficacy of AZD2014

Study identifier:D2270C00001

ClinicalTrials.gov identifier:NCT01026402

EudraCT identifier:2009-015244-42

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, open label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of the mTor Kinase Inhibitor AZD2014 administered orally to patients with advanced solid malignancies

Medical condition

Advanced solid malignancies

Phase

Phase 1

Healthy volunteers

Study drug

AZD2014

Sex

All

Actual Enrollment

172

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 01 Dec 2009

Primary Completion Date: 01 Aug 2014

Study Completion Date: 01 Aug 2014

Study design

Allocation: N/A
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: AZD2014 AZD2014 dose escalation phase in Part A and expansion phase in Part B.	Drug: AZD2014 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.

Arms

Assigned Interventions

Experimental: AZD2014
AZD2014 dose escalation phase in Part A and expansion phase in Part B.

Drug: AZD2014
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.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Dr. Udai Banerji

The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey SM2 5PT