NCT03907969

A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.

A Phase I/IIa, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD7648 Monotherapy or in Combination With Either Cytotoxic Chemotherapies or Novel Anti-Cancer Agents in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a modular Phase I/IIa, open-label, multi-centre, study of AZD7648 administered orally, either as a monotherapy, or in combination with either cytotoxic chemotherapies or novel anti-cancer agents in participants with advanced malignancies.

Detailed description

The modular design allows for an escalation of the dose of AZD7648 alone or in combination with either cytotoxic chemotherapies or novel anti-cancer agents, with intensive safety monitoring to ensure the safety of the participants. The study consists of 2 modules each evaluating the safety and tolerability of AZD7648 monotherapy or with a specific combination partner. Core module of the study is dose escalation (Part A) of AZD7648 monotherapy, administered orally, in participants with advanced solid tumours. Combination module 1 has 2 study parts: Part A consisting of dose escalation cohorts and Part B, a safety and proof of concept Phase IIa expansion. A Safety Review Committee will review evaluable participants at each cohort and assess if the study should progress to Part B.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	AZD7648	Core: AZD7648 will be administered orally
DRUG	PLD	The starting dose of PLD is 40 mg/m\^2, administered by intravenous infusion once every 4 weeks, for a maximum of 6 cycles

Timeline

• Start date: 2019-10-09
• Primary completion: 2022-12-07
• Completion: 2022-12-07
• First posted: 2019-04-09
• Last updated: 2024-02-06
• Results posted: 2024-02-06

Locations

5 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study