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AZD7648

Phase 1

Advanced Malignancies | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Feb 6, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

AZD7648 · 1 trial · 1 indication

Phase 1 1
NCT03907969A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.Advanced Malignancies
COMPLETED30 Analytics
PHASE1COMPLETED
A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.
Advanced Malignancies
NCT0390796930
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Study Endpoints

Primary Endpoints

Number of Patients With Adverse Events or Serious Adverse Events
From Screening (Day -28) till study drug discontinuation (3.2 years)

Safety and tolerability of AZD7648 when given orally to patients with advanced malignancies, as monotherapy and in combination with anti-cancer agents was assessed.

Number of Patients With Dose Limiting Toxicities (DLTs)
From Screening (Day -28) till study drug discontinuation (3.2 years)

A DLT is defined as an AE that occurs from the first dose of study treatment up to and including Cycle 1, Day 28 (the DLT assessment period) that is assessed as unrelated to the disease, intercurrent illness, or concomitant medications.

Secondary Endpoints

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf)
Monotherapy and Combination therapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose [each cycle is 28 days]
Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast)
Monotherapy and Combination therapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose (each cycle is 28 days)
Area Under Plasma Concentration-time Curve in the Dosing Interval τ (AUCτ)
Monotherapy and Combination therapy: Cycle 0 Day 1 Pre-dose to 72 hours post-dose (each cycle is 28 days)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Core Module: AZD7648 MonotherapyEXPERIMENTALAZD7648 will be administered orally on an empty stomach
Combination Module 1: AZD7648 + PLDEXPERIMENTALAZD7648 will be administered in combination with Pegylated liposomal doxorubicin (PLD)

Interventions

NameTypeDescription
AZD7648DRUGCore: AZD7648 will be administered orally
PLDDRUGThe starting dose of PLD is 40 mg/m\^2, administered by intravenous infusion once every 4 weeks, for a maximum of 6 cycles
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Eligibility Criteria

Age Range18 Years to 130 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Capable and willing to give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF). 2. Participant must be at least 18 years of age, at the time of signing the ICF. 3. Participants must have histologi...

Countries:United StatesUnited Kingdom
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Frequently asked questions about AZD7648

What is AZD7648 used for?

AZD7648 is an investigational small molecule being studied for the treatment of advanced malignancies. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced cancers, including those in the United States and United Kingdom.

What does AZD7648 target?

AZD7648 is a small molecule designed to target cancer cells in patients with advanced malignancies. While its specific molecular target is not disclosed in the available information, it is being studied as a potential treatment for advanced cancers. The drug is being evaluated alone and in combination with other anti-cancer agents.

Who makes AZD7648?

AZD7648 is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced malignancies.

What phase is AZD7648 in?

AZD7648 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is being studied for the treatment of advanced malignancies.

What clinical trials is AZD7648 in?

AZD7648 has been studied in one clinical trial with the identifier NCT03907969. This Phase 1 trial evaluated the drug alone and in combination with other anti-cancer agents in patients with advanced cancers. The trial enrolled 30 participants and has been completed. It was conducted in the United States and United Kingdom.

Is AZD7648 the same as any other drug?

AZD7648 is a unique investigational drug being developed by AstraZeneca. There are no alternative names provided for this drug in the available information. It is being studied as a potential treatment for advanced malignancies and is currently in Phase 1 clinical development.