Given that certain populations can respond differently to medical therapies, it is extremely important that this clinical trial include people from all races and ethnicities to ensure the study drug AZD4205 is safe and effective for everyone to use. — Dizal Pharmaceuticals' Commitment to Diversity
This trial is designed to see if the study drug AZD4205 is safe and tolerable and whether this treatment is effective in treating PTCL patients. This trial is an open-label study and there is no placebo.
This trial is testing:
This trial has two parts, including part A and part B:
Part A: Part A was conducted outside of the United States.
Part B: If you are eligible to participate, you will be participating in Part B of this trial. Approximately 100 participants will be enrolled in this trial. All participants in this part will take the study drug AZD4205 at the selected dose from Part A (AZD4205 of 150 mg once daily).
Sites are located in the cities/states identified with the red pin:
This trial has 4 periods: - Screening Period – Up to 28 days - Treatment Period – You will be treated until disease progression, unacceptable side effects, withdrawal of consent, or the study is terminated - Follow-up Period – Up to 28 days following the last dose of study drug - Long-term follow-up after disease progression Period – 3 months following confirmation of disease progression
The trial involves 1 screening visit, a variable number of treatment cycles and subsequent follow up visits. The screening visit will ensure that you are suitable to participate in the study. It may take up to 28 days before you start study treatment. By the end of the screening visit, the study doctor will determine if you are eligible to enter the treatment. If you will not be able to continue in the study, the study doctor will explain why and will discuss with you other treatment options.
If you are eligible for this trial, the subsequent visits will occur. Your study doctor will explain the study procedures and schedules to you in details.
You may have to be admitted to hospital for the 2~3 days of dosing for closer monitoring under some circumstances. Your study doctor will discuss with you.
The study drug (AZD4205) comes as capsule(s), which must be taken orally (by mouth) once per day at the same time each day. AZD4205 capsule(s) can be taken whole with water, with or without food.