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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04500587




Registration number
NCT04500587
Ethics application status
Date submitted
30/07/2020
Date registered
5/08/2020

Titles & IDs
Public title
Phase 1 First in Human Study of ZN-d5 as a Single Agent
Scientific title
Phase 1 First in Human Dose-Escalation Study of ZN-d5 as a Single Agent in Subjects With Non-Hodgkin Lymphoma or Acute Myeloid Leukemia
Secondary ID [1] 0 0
ZN-d5-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Non Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZN-d5

Experimental: ZN-d5 Single Agent Dose Escalation - NHL - Non-Hodgkin Lymphoma

Experimental: ZN-d5 Single Agent Dose Escalation - AML - Acute Myeloid Leukemia


Treatment: Drugs: ZN-d5
Oral agent; 25 mg or 100 mg formulation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Observed Dose Limiting Toxicities
Timepoint [1] 0 0
Through completion of Cycle 1; 1 to 2 months.
Primary outcome [2] 0 0
Incidence and severity of AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v 5.0
Timepoint [2] 0 0
Through study completion, typically < 12 months
Secondary outcome [1] 0 0
Pharmacokinetic parameters for ZN-d5 - Cmax
Timepoint [1] 0 0
approximately 6 months
Secondary outcome [2] 0 0
Pharmacokinetic parameters for ZN-d5 - Tmax
Timepoint [2] 0 0
approximately 6 months
Secondary outcome [3] 0 0
Pharmacokinetic parameters for ZN-d5 - AUC
Timepoint [3] 0 0
approximately 6 months
Secondary outcome [4] 0 0
For NHL, evaluate response according to the Lugano 2014 classification
Timepoint [4] 0 0
Through study completion, typically < 12 months
Secondary outcome [5] 0 0
For AML, remission rate based on European LeukemiaNet 2017 criteria
Timepoint [5] 0 0
Through study completion, typically < 12 months
Secondary outcome [6] 0 0
For AML, duration of remission based on European LeukemiaNet 2017 criteria
Timepoint [6] 0 0
Through study completion, typically < 12 months

Eligibility
Key inclusion criteria
Key

NHL: relapsed or refractory NHL including DLBCL, FL, MZL, MCL, LCL, LPL and PTC

* Subjects must have received at least 2 prior lines of therapy and have either failed or not be eligible for any available therapies expected to provide clinical benefit and have measurable disease.

AML: Primary, secondary, or treatment-related AML, relapsed or refractory to prior therapy, which may include failure of one cycle of induction therapy.

* White blood cell count < 25 × 109/L. Cytoreduction prior to treatment is acceptable.
* Subjects may not be pregnant and must agree to use an effective method of contraception.
* Eastern Cooperative Oncology Group performance status = 2.
* Estimated life expectancy of at least 12 weeks.
* Adequate hematologic and organ function, including creatinine clearance = 60 mL/min.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Recent interventions including major surgery, radiation therapy, stem cell transplant.
* Treatment with anti-neoplastic agents with 5 half-lives.
* Significant unresolved toxicity from prior treatments including active GVHD.
* Active central nervous system disease.
* Clinically substantial myocardial impairment.
* Prior therapy with venetoclax.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
115
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
Recruitment hospital [1] 0 0
Site 2708 - Darlinghurst
Recruitment hospital [2] 0 0
Site 2704 - Liverpool
Recruitment hospital [3] 0 0
Site 2710 - Kurralta Park
Recruitment hospital [4] 0 0
Site 2709 - Hobart
Recruitment postcode(s) [1] 0 0
- Darlinghurst
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Kurralta Park
Recruitment postcode(s) [4] 0 0
- Hobart
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Varna
Country [3] 0 0
Croatia
State/province [3] 0 0
Zagreb
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Pusan
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul
Country [6] 0 0
Poland
State/province [6] 0 0
Gdansk
Country [7] 0 0
Spain
State/province [7] 0 0
Barcelona
Country [8] 0 0
Spain
State/province [8] 0 0
Bilbao
Country [9] 0 0
Spain
State/province [9] 0 0
Valencia
Country [10] 0 0
Ukraine
State/province [10] 0 0
Kiev

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
K-Group Alpha Inc. /a subsidiary of Zentalis Pharmaceuticals
Address 0 0
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
K-Group Alpha Inc. /a subsidiary of Zentalis Pharmaceuticals
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04500587