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AZD5153

Phase 1

Malignant Solid Tumors | Small molecule | Oncology |AstraZeneca PLC|Last Updated: May 6, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

AZD5153 · 1 trial · 6 indications

Phase 1 1
NCT03205176AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including LymphomasMalignant Solid Tumors
COMPLETED49 Analytics
PHASE1COMPLETED
AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas
Malignant Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose-limiting toxicity (DLT).
From the first dose of study treatment up to last day of cycle 1 (21 days)

DLTs will be determined from monitoring adverse events (AEs), and abnormal laboratory tests (clinical chemistry, hematology, and urinalysis), physical examinations, vital signs (blood pressure and pulse), and electrocardiogram (ECG).

Secondary Endpoints

Peak plasma concentration (Cmax)
Samples for single dose PK will be collected at prespecified time points on Day 1, Cycle 1 pre-dose on Day 2. Multiple-dose PK will be assessed from samples taken on Days 15 and 16 of Cycle 1.
The urine concentration of AZD5153 and its co-former (if appropriate).
Urine will be collected pre-dose (spot sample), and volumetrically from 0-6, 6-12, 12-24 hours on Day 1 and Day 15 of Cycle 1.
The effect of AZD 5153 on QTc interval.
ECGs will be performed at prespecified time points on Days 1 and 2 and 15 and 16 of Cycle 1.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AZD5153 MonotherapyEXPERIMENTALPatients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine maximum tolerated dose (MTD). AZD5153 will be taken once per day (QD) or two times per day (BID) for 21 days as an oral capsule. Once the MTD is finalized, patients may be enrolled into an expansion cohort at the MTD.
AZD5153 + Olaparib Combination TherapyEXPERIMENTALPatients will be enrolled in cohorts of up to 6 patients each in a dose escalating scheme to determine MTD. AZD5153 will be taken as oral capsules BID in combination with 300 mg olaparib BID for 21 days.

Interventions

NameTypeDescription
AZD5153DRUGAZD5153 is to be taken as oral capsules once or twice per day each day in 21 day cycles. Dosing will continue until disease progression or other study discontinuation criteria are met.
OlaparibDRUGOlaparib, 300 mg, will be taken BID as oral capsules.
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria for all Patients: 1. Patient must be able to understand the nature of the study and provide a signed and dated, written informed consent prior to any study specific procedures, sampling or analyses. 2. Patients should have the ability and willingness to comply with the study and ...

Countries:United StatesCanada
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Frequently asked questions about AZD5153

What is AZD5153 used for?

AZD5153 is an investigational small molecule being studied for the treatment of malignant solid tumors, including lymphomas, ovarian cancer, breast cancer, pancreatic cancer, and prostate cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does AZD5153 target?

AZD5153 is a small molecule designed to target cancer cells in malignant solid tumors. Its specific molecular target has not been disclosed in available information, but it is being evaluated for its antitumor activity in patients with relapsed or refractory solid tumors, including lymphomas.

Who makes AZD5153?

AZD5153 is being developed by AstraZeneca PLC, a multinational pharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials for the treatment of malignant solid tumors.

What phase is AZD5153 in?

AZD5153 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug remains under evaluation for safety and efficacy in patients with solid tumors.

What clinical trials is AZD5153 in?

AZD5153 has been studied in one completed Phase 1 clinical trial, identified as NCT03205176, titled 'AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas.' The trial enrolled 49 patients across the United States and Canada and included conditions such as malignant solid tumors, lymphoma, ovarian, breast, pancreatic, and prostate cancer.

Is AZD5153 the same as any other drug?

AZD5153 is a distinct investigational compound developed by AstraZeneca. No alternative names for AZD5153 have been reported in available clinical trial information. It is being studied as a monotherapy in a Phase 1 trial for advanced solid tumors.