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

Sponsor

Dizal Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04105010

Collaborator

(none)

160

Enrollment

Locations

Arms

45.7

Anticipated Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory Peripheral T Cell Lymphoma	Drug: AZD4205	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Actual Study Start Date :

Sep 10, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AZD4205 Group A Group A: Open label AZD4205 at dose A, once daily (Phase 1)	Drug: AZD4205 AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: AZD4205 Group B Group B: Open label AZD4205 at dose B, once daily (Phase 1)	Drug: AZD4205 AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: AZD4205 Group C Group C: Open label AZD4205 at a selected dose, once daily (Phase 1)	Drug: AZD4205 AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
Experimental: AZD4205 Group D Group D: Open label AZD4205 at the RP2D, once daily (Phase 2)	Drug: AZD4205 AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) [Through study completion, an average of 1 year]
ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans per Lugano criteria

Secondary Outcome Measures

Incidence of adverse events [The first dose until 28 days after last dose]
To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs)
Peak Plasma Concentration (Cmax) of AZD4205 [1,8,15, 21 days after first dose]
Area under the plasma concentration versus time curve (AUC) of AZD4205 [1,8,15, 21 days after first dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale Cancer Center	New Haven	Connecticut	United States	06510
2	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
3	Northwestern Memorial Hospital	Chicago	Illinois	United States	60611
4	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
5	Epworth Hospital	East Melbourne		Australia
6	St Vincent's Hospital Melbourne	Fitzroy		Australia
7	Royal Hobart Hospital	Hobart		Australia
8	St George Hospital	Kogarah		Australia
9	Royal Perth Hospital	Perth		Australia
10	Westmead Hospital	Westmead		Australia
11	Beijing Cancer Hospital	Beijing		China
12	Beijing Friendship Hospital, Capital Medical University	Beijing		China
13	Beijing hospital	Beijing		China
14	Peking University Third Hospital	Beijing		China
15	The First Hospital of Jilin University	Changchun		China
16	Hunan Cancer hospital	Changsha		China
17	Xiangya Hospital Central South University	Changsha		China
18	Sichuan University - West China Hospital	Chengdu		China
19	Chongqing University Cancer Hospital	Chongqing		China
20	The Second Hospital of Dalian Medical University	Dalian		China
21	Guangdong Provincial People's Hospital	Guangzhou		China
22	NanFang Hospital of Southern Medical University	Guangzhou		China
23	Sun Yat-sen University Cancer Center	Guangzhou		China
24	Hainan Cancer Hospital	Haikou		China
25	Hainan General Hospital	Haikou		China
26	The First Affiliated Hospital of Zhejiang University	Hangzhou		China
27	Zhejiang Cancer Hospital	Hangzhou		China
28	Anhui Provincial Cancer Hospital	Hefei		China
29	The Second Hospital of Anhui Medical University	Hefei		China
30	Shandong Cancer Hospital	Jinan		China
31	The First Hospital of Lanzhou University	Lanzhou		China
32	Linyi Cancer Hospital	Linyi		China
33	Jiangxi Province Cancer Hospital	Nanchang		China
34	The First Affiliated Hospital of Nanchang University	Nanchang		China
35	Jiangsu Cancer Hospital	Nanjing		China
36	Fudan University Shanghai Cancer Center	Shanghai		China
37	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai		China
38	The First Affiliated Hospital of Soochow University	Suzhou		China
39	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China
40	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan		China
41	The First Affiliated Hospital of Xiamen University	Xiamen		China
42	Henan Cancer Hospital	Zhengzhou		China
43	Inje University Busan Paik Hospital	Busan		Korea, Republic of
44	Pusan National University Hospital	Busan		Korea, Republic of
45	Keimyung University Dongsan Hospital	Daegu		Korea, Republic of
46	National Cancer Center	Goyang		Korea, Republic of
47	Chonbuk National University Hospital	Jeonju		Korea, Republic of
48	Seoul National University Bundang Hospital	Seongnam		Korea, Republic of
49	Samsung Medical Center	Seoul		Korea, Republic of	06133
50	Asan Medical Center	Seoul		Korea, Republic of
51	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Dizal Pharmaceuticals

Investigators

Principal Investigator: Won Seog Kim, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dizal Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT04105010

Other Study ID Numbers:

DZ2019J0005

First Posted:

Sep 26, 2019

Last Update Posted:

Jan 28, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Jan 28, 2022