Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)

Completed · Phase 1/Phase 2

Conditions studied: Relapsed or Refractory Peripheral T Cell Lymphoma

In brief

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 monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment. Phase 1 part: Around 20\~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10\~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts. Phase 2 part: After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.

Key facts

Study ID: NCT04105010
Run by: Dizal Pharmaceuticals
People needed: 171
Starts: 2019-09-10
Expected to finish: 2024-02-22
Last updated by the study team: 2025-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Obtained written informed consent
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.
Patients must have measurable disease according to the Lugano criteria.
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.
Adequate bone marrow reserve and organ system functions.

You may not qualify if…

Any unsolved toxicity > Common Terminology Criteria for Adverse Events (CTCAE) grade 1 from previous anti-cancer therapy (except alopecia).
Active infections, active or latent tuberculosis.
Patients with 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. Patient had autologous stem cell transplant within 6 months.

Where it is running

Yale Cancer Center — New Haven, Connecticut, United States
Winship Cancer Institute — Atlanta, Georgia, United States
Washington University School of Medicine — St Louis, Missouri, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Epworth Hospital — East Melbourne, Australia
St Vincent's Hospital Melbourne — Fitzroy, Australia
Royal Hobart Hospital — Hobart, Australia
St George Hospital — Kogarah, Australia
Royal Perth Hospital — Perth, Australia
Westmead Hospital — Westmead, Australia
Beijing Cancer Hospital — Beijing, China
Beijing Friendship Hospital, Capital Medical University — Beijing, China
Beijing Hospital — Beijing, China
Peking University Third Hospital — Beijing, China
The First Hospital of Jilin University — Changchun, China
Hunan Cancer Hospital — Changsha, China
Xiangya Hospital Central South University — Changsha, China
Sichuan University - West China Hospital — Chengdu, China
Chongqing University Cancer Hospital — Chongqing, China
The Second Hospital of Dalian Medical University — Dalian, China
Guangdong Provincial People's Hospital — Guangzhou, China
NanFang Hospital of Southern Medical University — Guangzhou, China
Sun Yat-sen University Cancer Center — Guangzhou, China
Hainan General Hospital — Haikou, China
The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China

Full record on ClinicalTrials.gov

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