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Closed (no longer recruiting)Last updated: 4 March 2024

This Phase I/II trial is evaluating how safe and tolerable a new oral targeted therapy (AZD4205) is in people with peripheral T-Cell lymphomaA Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients With Peripheral T Cell Lymphoma (PTCL)

Clinical summary

Summary

This is a non-randomised trial with two phases. Phase 1 involves around 20-40 participants being subsequently enrolled into 2 different dose ascending cohorts. An additional 10-20 participants may be enrolled to further explore a selected dose defined by dose escalation cohorts. After the recommended phase 2 dose (RP2D) is defined, a phase 2 dingle-arm, open-label pivotal study will be conducted to assess anti-tumour efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.

Conditions

This trial is treating patients with relapsed or refractory peripheral T-Cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Dizal Pharmaceuticals

Scientific Title

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

Eligibility

Inclusion

  1. Obtained written informed consent
  2. Patients must have histologically confirmed peripheral T-cell lymphoma according to the 2016 revision of the World Health Organization classification of lymphoid neoplasms. Tumor samples are required for central pathology review to confirm the diagnosis.
  3. Patients must have measurable disease according to the Lugano criteria.
  4. Patients should be transplant-ineligible upon their entry into this study, and must have relapsed after or been refractory/intolerant to ≥ 1 (but not > 3) prior systemic therapy(ies) for PTCL.
  5. Adequate bone marrow reserve and organ system functions.

Exclusion

  1. Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia).
  2. Active infections, active or latent tuberculosis.
  3. Patients with severely decreased lung function.
  4. History of heart failure or QT interval prolongation.
  5. Central nervous system (CNS) or leptomeningeal lymphoma.
  6. History of treatment with Janus kinase (JAK) or signal transducer and activator of transcription 3 (STAT3) inhibitor.
  7. Patient has undergone an allogeneic stem cell transplant. Patient had autologous stem cell transplant within 6 months.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Closed hospitals

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