A Phase II, Open-Label, Single-Arm Study to Investigate the Safety, Tolerability, and Anti-tumor Activity of AZD4205 Treating Relapsed or Refractory Peripheral T Cell Lymphoma (r/r PTCL)

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Eligible participants are those who had pathologically confirmed PTCL and have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen. The primary objective of this study is to evaluate anti-tumor efficacy of AZD4205 at 150 mg once daily (RP2D) in participants with r/r PTCL. The safety, tolerability, and PK of AZD4205 in r/r PTCL at RP2D will also be investigated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 18 years old (for Korean ≥ 19 years old)

• ECOG performance status 0-2 with no deterioration over the previous 2 weeks

• Predicted life expectancy ≥ 12 weeks.

• Histologically confirmed PTCL by local pathology review according to the 2016 revision of the WHO classification of lymphoid neoplasms. Eligible histological subtypes are restricted to the following:

‣ PTCL-NOS

⁃ AITL

⁃ ALCL ALK+

⁃ EATL

⁃ MEITL

⁃ NKTCL

⁃ HSTCL

⁃ SPTCL

• Have measurable disease according to the 2014 Lugano classification

• Must have progressed on or are refractory to standard systemic therapy, or patients were intolerant to standard systemic therapy. Participants should be transplant-ineligible upon their entries to this study.

• Adequate bone marrow reserve and organ system functions

• LVEF ≥ 55% assessed by ECHO or MUGA.

• Male participant with female partners of child-bearing potential should be willing to use barrier contraceptives (i.e., by use of condoms), during his participation in this study and for 6 months following the last dose of the study drug. Male participant must refrain from donating sperm during their participation in the study and at least for 6 months after the last treatment.

⁃ Female participant should be using adequate contraceptive measures while on study drug and for 3 months following the last dose of study drug.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Bethune Hospital of Jilin University
RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing Cancer Hospital
RECRUITING
Chongqing
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Hainan General Hospital
RECRUITING
Haikou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
RECRUITING
Hefei
The Second Hospital of Anhui Meidcine University
RECRUITING
Hefei
Shandong Cancer Hospital & Insititution
RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Cancer Hospital
RECRUITING
Nanjing
Ruijing Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Tianjin Medical University Cancer Institute & Hospital
RECRUITING
Tianjin
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Rika Chen
Rika.Chen@dizalpharma.com
+86(21)-61095875
Time Frame
Start Date: 2022-05-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 150
Treatments
Experimental: AZD4205 treatment
Cohort 1: Newly enrolled participants with r/r PTCL who were never exposed to AZD4205 (receive 150 mg or 75 mg). Cohort 2: Participants from other completed AZD4205 study if they are still benefiting from AZD4205 (receive 150 mg).
Sponsors
Leads: Dizal Pharmaceuticals

This content was sourced from clinicaltrials.gov

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