Trial Title:
AZD4205 in Relapsed or Refractory Peripheral T Cell Lymphoma (JACKPOT27)
NCT ID:
NCT06511895
Condition:
Peripheral T Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AZD4205
Description:
AZD4205 capsules administered at 150 mg orally, once daily, in 28-day cycle.
Arm group label:
AZD4205 treatment
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.
Criteria for eligibility:
Criteria:
Inclusion criteria:
1. ≥ 18 years old (for Korean ≥ 19 years old)
2. ECOG performance status 0-2 with no deterioration over the previous 2 weeks
3. Predicted life expectancy ≥ 12 weeks.
4. 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+
- ALCL ALK-
- EATL
- MEITL
- NKTCL
- HSTCL
- SPTCL
5. Have measurable disease according to the 2014 Lugano classification
6. 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.
7. Adequate bone marrow reserve and organ system functions
8. LVEF ≥ 55% assessed by ECHO or MUGA.
9. 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.
10. Female participant should be using adequate contraceptive measures while on study
drug and for 3 months following the last dose of study drug.
Exclusion criteria:
1. Intervention with any of the following:
- Any investigational agents or study drugs from a previous clinical study within
30 days of the first dose of study treatment.
- Any cytotoxic chemotherapy from a previous treatment regimen within 21 days of
the first dose of study treatment.
- Prior HDAC inhibitors (including romidepsin, belinostat and chidamide) or
pralatrexate therapy within one week of the start of the study treatment.
- Corticosteroids at dosages equivalent to prednisone > 15 mg/day within 7 days
of the start of the study treatment.
- Major surgery procedure (excluding placement of vascular access), or
significant traumatic injury within 4 weeks of the first dose of study
treatment, or have an anticipated need for major surgery during the study.
- Prior therapeutic anticancer antibodies (including brentuximab vedotin) within
4 weeks, other radio- or toxin-immunoconjugates within 10 weeks, radiation
therapy within 3 weeks.
- Has undergone an allogeneic stem cell transplant. Participant had autologous
stem cell transplant within 6 months.
- Prior treatment with a JAK or STAT3 inhibitor.
- Prior treatment with any onco-immunotherapy in 28 days prior to first dosing of
AZD4205.
- Live vaccines within 28 days prior to first dose.
- Currently receiving (or unable to stop use at least 1 week prior to receiving
the first dose) vitamin K antagonists, anti-platelet agents or anticoagulated
agents.
- Currently receiving (or unable to stop use at least 1 week prior to receiving
the first dose) medications or herbal supplements known to be potent inhibitors
or inducers of CYP3A or sensitive substrates of BCRP or P-gp with narrow
therapeutic index.
2. Any unresolved toxicities from prior therapy, greater than CTCAE v 5.0 Grade 1 at
the time of starting study treatment with the exception of alopecia.
3. Central nervous system or leptomeningeal lymphoma.
4. With severely decreased lung function (i.e. any parameter of FEV1, and DLCO < 60% of
predicted value). Past medical history of pneumonitis, drug-induced interstitial
lung disease, radiation pneumonitis which required steroid treatment, or any
evidence of clinically active interstitial lung disease.
5. With disease condition which requires the treatment of immunosuppressants,
biologics, or NSAIDs (non-steroid anti-inflammatory drugs).
6. Active infections including:
- History of known latent or active tuberculosis (TB).
- Known infection with HIV, or serologic status reflecting active hepatitis B or
hepatitis C infection.
- Active viral infections (i.e. zoster) other than hepatitis B or C.
- Infections requiring oral or intravenous antimicrobial therapy or interferon.
- Bacterial infections including pneumonia within 30 days.
7. Any of the following cardiac criteria:
- Congestive heart failure (CHF) per NYHA classification > Class II.
- Clinically significant valvular diseases, hypertrophic or constrictive
cardiomyopathy.
- Any clinically significant abnormalities in rhythm, conduction or morphology of
resting ECG, e.g., complete left bundle branch block, third degree heart block,
and second-degree heart block, PR interval > 250 msec.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- AMI within 6 months prior to starting treatment, unstable angina or new-onset
angina.
- With heart transplant.
- Mean resting corrected QTcF interval (QTC) > 450 ms on ECG.
- With factors that increase the risk of QT prolongation or arrhythmic events
(e.g., heart failure, hypokalaemia, congenital long QT syndrome, any
concomitant medication known to prolong the QT interval) or family history of
long QT interval syndrome or unexplained sudden death under 40 years of age in
first degree relatives.
- With previous/current thrombotic diseases such as pulmonary embolism, and deep
venous thrombosis.
8. Another malignancy within 5 years prior to enrollment with the exception of
adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell
carcinoma or non-melanomatous skin cancer.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Hospital (The First Affiliated Hospital of USTC)
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Kaiyang Ding
Facility:
Name:
The Second Hospital of Anhui Meidcine University
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhimin Zhai
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuqin Song
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongmei Jing
Facility:
Name:
Chongqing Cancer Hospital
Address:
City:
Chongqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Yang
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenyu Li
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingqing Cai
Facility:
Name:
Hainan General Hospital
Address:
City:
Haikou
Country:
China
Status:
Recruiting
Contact:
Last name:
Li'er Lin
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Liling Zhang
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Zhou
Facility:
Name:
Jiangsu Cancer Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianqiu Wu
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
The First Bethune Hospital of Jilin University
Address:
City:
Changchun
Country:
China
Status:
Recruiting
Contact:
Last name:
Sujun Gao
Facility:
Name:
Shandong Cancer Hospital & Insititution
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Zengjun Li
Facility:
Name:
Ruijing Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Weili Zhao
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Contact:
Last name:
Liqun Zou
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengzi Qian
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiyan Yang
Start date:
May 31, 2022
Completion date:
December 2026
Lead sponsor:
Agency:
Dizal Pharmaceuticals
Agency class:
Industry
Source:
Dizal Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06511895
