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Administration of AZD6738

Phase 1

11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL), | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jun 19, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment2
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01955668AZD6738 First Time in Patient Multiple Ascending Dose StudyPHASE1 COMPLETED 2 — — Nov 1, 2013Dec 1, 2013Jun 19, 20141 United States
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Study Endpoints
Primary Endpoints
Parts A and B: Safety and tolerability in terms of AE and SAE (including death), as recorded in safety measures.
From baseline until 28 days after discontinuation of study treatment, assessed up to 29 months

Safety measures include ECG, physical examination, pulse, blood pressure, body temperature, respiratory rate, weight and laboratory variables

Secondary Endpoints
Part A only: Define either the Maximum tolerated dose (MTD), if possible, or maximum feasible dose (MFD)
DLT's assessed during the 21 day assessment period
Part B only: Preliminary assessment of the effect of food on the Pharmacokinetic (PK) parameters of AZD6738 via plasma analysis
Blood Samples - Cycle 1 Day 1 for fasted patients at: Pre-Dose, 0.25,0.5,1,2,3,4,6 and 8 hrs post dose. For fed patients Cycle 1, Day 2 :Pre-Dose, 0.25,0.5,1,2,3,4,6 and 8 post dose.
Parts A&B: Establish pharmacokinetics characteristics of AZD6738 and its active metabolite from plasma analysis
Part A Day 1 Single Dosing (predose, 0.25.0.5,1,2,3,4,6,8 24h); Part A - Multiple Dosing Cycle 1 Day 1 and Day 8 (pre-dose, 0.25,0.51,2,3,4,6 and 8). C1D15 (Pre-dose, 1hr). Part B: C1D1: (Pre-dose,0.25.5,1,2,3,4,6,8,24) and at C1D15(pre-dose,1)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD6738EXPERIMENTALPatients will receive a single dose on day 1 followed by ongoing multiple dosing until MTD or MFD is reached.
Interventions
NameTypeDescription
Administration of AZD6738DRUGAn oral formulation of AZD6738 will be used. The starting dose of 20 mg BD will be escalated to reach a maximum tolerated dose in patients as defined by dose-limiting toxicity. A '3 week on, 1 week off' schedule, as deemed optimal in modelling of data from non-clinical studies, will be used initially
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. 2. For the dose escalation phase, Part A, histological or cytological confirmation of relapsed or refractory B cell malignancy, including CLL, PLL, Burkitt l...

Countries:United States
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