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AZD5312 · 1 trial · 1 indication
The patient population used for determination of the MTD will consist of patients who have met the minimum safety evaluation requirements of the study, and/or who have experienced a DLT. Minimum safety requirements will be met if, during Cycle 1 of treatment, the patient receives all doses of AZD5312, completes all required safety evaluations, and is observed for at least 28 days following the first dose of AZD5312.
•3 evaluable patients (pts) will be enrolled at each dose level (3+3 design) •Evaluated for 28 days before escalation to next dose level. •If more than 1 experiences Dose Limiting Toxicity (DLT), additional 3 patients treated with the same dose. •Maximum of 6 pts enrolled per dose level. •100% increase in dosing until 2 pts (out of 3) at dose level experience toxicity of ≥ Grade 2, or 1 pt. experiences DLT. •Accelerated titration stopped, and subsequent dose escalation will be ≤ 50%. •Evaluation of a cohort of at least 3 patients completing 1 cycle of treatment (28 days) required prior to next dose level. •Dose escalation decisions take into account safety profile of prior dose groups, and available PK data. •Additional patients may be enrolled at lower doses for sufficient PK data. •Intermediate dose levels evaluated to declare the recommended Phase II dose (RP2D). When R2PD is determined, 12 patients will be treated at that dose level to further evaluate safety and efficacy.
| Arm | Type | Description |
|---|---|---|
| AZD5312 | EXPERIMENTAL | AZD5312 will be given intravenously (IV) as an infusion, over one hour. For the purpose of planning, each 4 week period (28 days) will be called a Cycle. AZD5312 will initially be administered 4 times within the first 11 days, (on Days \[1, 4, 8 and 11\]± 2), with no dosing on sequential days. Patients will receive weekly treatments on Days 15 and 22 to complete Cycle 1\. During the subsequent cycles, patients will receive weekly treatment on Days 1, 8, 15 and 22 (±2). |
| Name | Type | Description |
|---|---|---|
| AZD5312 | DRUG | AZD5312 is a generation 2.5 antisense oligonucleotide (ASO) which is designed with the purpose of specifically suppressing human Androgen Receptor (AR) expression, thereby providing potential therapeutic benefit for the treatment of mCRPC and other AR-dependent cancers. |
Inclusion criteria. * Patient must understand nature of trial and provide a signed and dated, written informed consent form prior to study specific procedures, sampling and analyses. If a patient declines to participate in voluntary exploratory research and/or genetic component of study, there will...
AZD5312 is an investigational small molecule being studied for the treatment of advanced solid tumours where the androgen receptor pathway is a potential factor. It is in Phase 1 clinical development for this oncology indication.
AZD5312 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN.
AZD5312 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed.
AZD5312 has been studied in a Phase 1 open-label dose escalation trial, identified as NCT02144051. This trial investigated the safety and pharmacokinetics of AZD5312 in patients with androgen receptor tumours and has been completed.
AZD5312 is the primary name for this investigational drug. No alternative names have been reported for this compound.