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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

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment2

FDA Designations

No designations recorded

Clinical trial landscape

Administration of AZD6738 · 1 trial · 3 indications

Phase 1 1
NCT01955668AZD6738 First Time in Patient Multiple Ascending Dose Study11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL),
COMPLETED2 Analytics
PHASE1COMPLETED
AZD6738 First Time in Patient Multiple Ascending Dose Study
11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL),Unlock trial analytics

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 to 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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Frequently asked questions about Administration of AZD6738

What is AZD6738 used for?

AZD6738 is an investigational small molecule being studied for the treatment of 11q-deleted relapsed/refractory chronic lymphocytic leukaemia (CLL), prolymphocytic leukaemia (PLL), and B cell lymphomas. It is in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes AZD6738?

AZD6738 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is AZD6738 in?

AZD6738 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy.

What clinical trials is AZD6738 in?

AZD6738 has been studied in one completed Phase 1 clinical trial, identified as NCT01955668, titled "AZD6738 First Time in Patient Multiple Ascending Dose Study." This trial enrolled 2 participants with conditions including 11q-deleted relapsed/refractory chronic lymphocytic leukaemia, prolymphocytic leukaemia, and B cell lymphomas.

Is AZD6738 the same as ceralasertib?

AZD6738 is also known as ceralasertib. It is an investigational small molecule being developed by AstraZeneca for the treatment of certain haematological malignancies, including 11q-deleted relapsed/refractory chronic lymphocytic leukaemia.