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Administration of AZD6738 · 1 trial · 3 indications
Safety measures include ECG, physical examination, pulse, blood pressure, body temperature, respiratory rate, weight and laboratory variables
| Arm | Type | Description |
|---|---|---|
| AZD6738 | EXPERIMENTAL | Patients will receive a single dose on day 1 followed by ongoing multiple dosing until MTD or MFD is reached. |
| Name | Type | Description |
|---|---|---|
| Administration of AZD6738 | DRUG | 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 |
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...
AZD6738 is an investigational small molecule being studied in oncology for 11q-deleted relapsed or refractory chronic lymphocytic leukaemia (CLL). It has also been evaluated in prolymphocytic leukaemia (PLL) and B cell lymphomas. It is a Phase 1 agent and is not approved for any indication.
AZD6738 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the Phase 1 first-time-in-patient multiple ascending dose study of the drug.
AZD6738 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The single Phase 1 trial of AZD6738 has been completed, and no trials are currently active.
AZD6738 has been studied in one Phase 1 trial, NCT01955668, titled AZD6738 First Time in Patient Multiple Ascending Dose Study. The trial enrolled 2 participants, was conducted in the United States, and is completed. It was an uncontrolled, non-randomized, open-label study in adults 18 years and older.
Yes. The AZD6738 Phase 1 trial NCT01955668 was biomarker-selected, enrolling patients with 11q-deleted relapsed or refractory chronic lymphocytic leukaemia (CLL). The study also included prolymphocytic leukaemia (PLL) and B cell lymphomas, and enrolled 2 participants in total.