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.

What Will Happen in This Trial?

Sites are located in the cities/states identified with the red pin:

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.

Frequently Asked Questions (FAQs)

Will I get paid to be a part of this clinical trial?

There are no additional costs associated with participating in this trial, nor will you be paid. Study drugs, tests and medical care required as part of this trial will be provided at no cost.

You may be reimbursed for any reasonable travel, parking, meals and other expenses associated with the study visits, We want to make sure this is not too much of a burden for you. The study site will review all these details with you.

How can I check to see if I’m eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new vaccines or treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I quit the trial at any time?

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, gender, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples and any images taken.

Study volunteers have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the participant’s safety, or if the participant no longer meets the study requirements.

Who has access to your personal information?

All your personal information collected for this study will be securely stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others who have a need to know such as our data hosting provider, and government regulators may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by TrialScope to contact you about clinical trials and related information.

This trial is not actively recruiting.

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 Information

Estimated Enrollment

Phase

Eligibility Criteria

Participants must:

Participants must not:

What Will Happen in This Trial?

What’s Involved

Frequently Asked Questions (FAQs)