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

• ClinicalTrials.gov Identifier: NCT04105010
• Recruitment Status: Recruiting
• First Posted: September 26, 2019
• Last Update Posted: August 26, 2022
• Sponsor: Dizal Pharmaceuticals
• Information provided by (Responsible Party): Dizal Pharmaceuticals

Tracking Information

• First Submitted Date: September 18, 2019
• First Posted Date: September 26, 2019
• Last Update Posted Date: August 26, 2022
• Actual Study Start Date: September 10, 2019
• Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 29, 2020)

Objective Response Rate (ORR) [ Time Frame: 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

Original Primary Outcome Measures (submitted: September 24, 2019)

Incidence of Adverse Events [ Time Frame: From first dose until 28 days after last dose ]

To evaluate the safety and tolerability of AZD4205 in patients with peripheral T cell lymphoma (PTCL) at different dose levels in terms of adverse events (AEs)

Current Secondary Outcome Measures (submitted: November 29, 2020)

• Incidence of adverse events [ Time Frame: 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 [ Time Frame: 1,8,15, 21 days after first dose ]
• Area under the plasma concentration versus time curve (AUC) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]

Original Secondary Outcome Measures (submitted: September 24, 2019)

• Objective Response Rate (ORR) [ Time Frame: Through study completion, an average of 1 year ]
  Per Lugano 2014 criteria for assessing FDG-PET/CT in lymphoma: ORR is the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR), prior to progression or further anti-cancer therapy
• Peak Plasma Concentration (Cmax) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]
• Area under the plasma concentration versus time curve (AUC) of AZD4205 [ Time Frame: 1,8,15, 21 days after first dose ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Relapsed or Refractory Peripheral T Cell Lymphoma

Intervention

Drug: AZD4205

AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions

Study Arms

• Experimental: AZD4205 Group A
  Group A: Open label AZD4205 at dose A, once daily (Phase 1)
  Intervention: Drug: AZD4205
• Experimental: AZD4205 Group B
  Group B: Open label AZD4205 at dose B, once daily (Phase 1)
  Intervention: Drug: AZD4205
• Experimental: AZD4205 Group C
  Group C: Open label AZD4205 at a selected dose, once daily (Phase 1)
  Intervention: Drug: AZD4205
• Experimental: AZD4205 Group D
  Group D: Open label AZD4205 at the RP2D, once daily (Phase 2)
  Intervention: Drug: AZD4205

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 31, 2020): 160
• Original Estimated Enrollment (submitted: September 24, 2019): 100
• Estimated Study Completion Date: July 2023
• Estimated Primary Completion Date: January 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jason Li, MD; 862161097868; jason.li@dizalpharma.com

Contact: Pamela Yang, MD, PhD

• Listed Location Countries: Australia, China, Korea, Republic of, United States

Administrative Information

• NCT Number: NCT04105010
• Other Study ID Numbers: DZ2019J0005
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dizal Pharmaceuticals
• Original Responsible Party: Dizal (Jiangsu) Pharmaceutical Co., Ltd.
• Current Study Sponsor: Dizal Pharmaceuticals
• Original Study Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Dizal Pharmaceuticals
• Verification Date: August 2022