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AZD6738 First Time in Patient Multiple Ascending Dose Study | Clinical Trials | Clareo Health

COMPLETEDPHASE1

AZD6738 First Time in Patient Multiple Ascending Dose Study

A Two-part Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of Multiple Ascending Doses of AZD6738 in Patients With Relapsed/Refractory B Cell Malignancies With Expansion to Patients With Prospectively Identified 11q-deleted or ATM-deficient, Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL)

NCT01955668•AstraZeneca

View on ClinicalTrials.gov

Summary

In Part A to investigate the safety and tolerability of AZD6738 when given orally to patients with relapsed/refractory CLL, PLL or B cell lymphoma. In Part B to investigate the safety and tolerability of AZD6738 when given orally to patients with prospectively identified 11q deleted or ATM deficient, relapsed/refractory CLL

Detailed Description

In this first time in patient study, AZD6738 will be administered to patients with relapsed/refractory chronic lymphocytic leukaemia (CLL), prolymphocytic leukaemia (PLL) or B cell lymphomas, primarily to determine the safety and tolerability of AZD6738. Pharmacokinetics of AZD6738 and potential biological activity will also be investigated. An oral formulation of AZD6738 will be used. The starting dose of 20 mg twice daily (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. Following the dose escalation phase of the study, additional patients with prospectively identified 11q-deleted or ATM deficient relapsed/refractory CLL will be enrolled to a dose expansion phase to explore further the safety, tolerability, pharmacokinetics and biological activity at selected dose(s)/schedule(s).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 lymphoma/Burkitt cell leukaemia, acute lymphocytic leukaemia, hairy cell leukaemia (HCL) and aggressive and indolent B cell lymphoma, not considered to be appropriate for further conventional treatment.
•For the dose expansion phase, Part B, histological or cytological confirmation of relapsed or refractory 11q-deleted or ATM-deficient CLL, not considered to be appropriate for further conventional treatment.
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks and an estimated life expectancy of greater than 16 weeks.
•4. Not known to be positive for HIV antibody, Hepatitis B surface antigen and Hepatitis C antibody.
•5. Females must be using adequate contraceptive measures, must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
•* Post menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
•* Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
•* Amenorrhoeic for 12 months and serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and plasma oestradiol levels in the postmenopausal range for the institution.
•6. Ability to swallow and retain oral medication

Exclusion Criteria

•1. Receiving, or having received during the four weeks prior to study entry (signing of consent), treatment for their malignancy.
•2. Receiving, or having received during the four weeks prior to study entry (signing of consent), corticosteroids (at a dose \> 10 mg prednisone/day or equivalent) for any reason.
•3. A known hypersensitivity to AZD6738 or any excipient of the product.
•4. Treatment with any investigational medicinal product (IMP) within 28 days prior to signing of consent.
•5. Receiving, or having received, concomitant medications, herbal supplements and/or foods that significantly modulate CYP3A4 or Pgp activity (wash out periods of two weeks, but three weeks for St. John's Wort). Note these include common azole antifungals, macrolide antibiotics.
•6. Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
•1. Albumin \< 33g/L
•2. AST or ALT \> 2.5 x ULN
•3. Total bilirubin \> 1.5 x ULN
•4. Alkaline phosphatase \> 2.5 x ULN
+19 more criteria

Locations (1)

Research Site

La Jolla, California, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2013

Last Updated

June 19, 2014

Enrollment

ACTUAL participants

Conditions

11q-deleted Relapsed/Refractory Chronic Lymphocytic Leukaemia (CLL),Prolymphocytic Leukaemia (PLL)B Cell Lymphomas

Interventions

Administration of AZD6738

DRUG

Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas

NCT03920631

B Cell Lymphomas

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 19, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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