A Phase I/II, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients with Peripheral T Cell Lymphoma (PTCL)

Trial ID: NCT04105010
This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as a monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment.
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

Trial Information

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:

  • Safety and tolerability: side effects of the study drug AZD4205,
  • Pharmacokinetics: how the body processes the study drug, and
  • Anti-tumor activity: what effect the study drug AZD4205 brings to the cancer.

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).

Estimated Enrollment

10 Participants

Phase

Phase 2

Eligibility Criteria

Participants must:

  • Have been diagnosed with peripheral T-cell lymphoma
  • Be willing to provide tumor samples for central pathology review .
  • Have measurable disease according to the LUGANO criteria.
  • Be transplant-ineligible upon entry into this trial, and must have relapsed after or been intolerant to ≥ 1 (but not > 3) prior systemic therapy(ies) for PTCL.
  • Adequate bone marrow reserve and organ system functions.

Participants must not:

  • Ongoing moderate or severe side efforts from previous anti-cancer therapy - (except alopecia is allowed).
  • Active infections, active or latent tuberculosis.
  • Severely decreased lung function.
  • History of heart failure or QT interval prolongation.
  • Central nervous system (CNS) or leptomeningeal lymphoma.
  • History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor.
  • Patient has undergone an allogeneic stem cell transplant or an autologous stem cell transplant within last 6 months.

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What Will Happen in This Trial?

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What’s Involved

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.

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We'll check to see if you are eligible by asking you some questions.

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Frequently Asked Questions (FAQs)