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AZD6738 First Time in Patient Multiple Ascending Dose Study

NCT01955668 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2014-06-19

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Administration of AZD6738

An 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

Sponsors & Collaborators

  • CLL Consortium

    collaborator UNKNOWN

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Michael Choi, MD · UCSD and CLL Consortium

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01955668 on ClinicalTrials.gov