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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03768505




Registration number
NCT03768505
Ethics application status
Date submitted
4/12/2018
Date registered
7/12/2018

Titles & IDs
Public title
Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)
Scientific title
A Multicenter, Open Label Single-Arm, Phase 2 Study of Zandelisib (ME-401) in Subjects With Follicular Lymphoma and Marginal Zone Lymphoma After Failure of Two or More Prior Systemic Therapies (The TIDAL Study)
Secondary ID [1] 0 0
2018-002896-17
Secondary ID [2] 0 0
ME-401-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma (FL) 0 0
Non Hodgkin Lymphoma 0 0
Marginal Zone 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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zandelisib (ME-401)

Experimental: Zandelisib (ME-401) open label - Subjects with relapsed/refractory FL or MZL will be administered 60 mg of ME-401 orally, once a day on an intermittent schedule (IS).


Treatment: Drugs: Zandelisib (ME-401)
Zandelisib (ME-401) 60 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) of ME-401 in Relapsed or Refractory FL or MZL
Timepoint [1] 0 0
3 years 9 months
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
3 years 9 months
Secondary outcome [2] 0 0
Complete Response (CR) Rate
Timepoint [2] 0 0
3 years 9 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
3 years 9 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Overall Incidence of Treatment Emergent Adverse Events (TEAEs)
Timepoint [5] 0 0
3 years 9 months
Secondary outcome [6] 0 0
PK of ME-401
Timepoint [6] 0 0
3 years 9 months

Eligibility
Key inclusion criteria
* Histologically confirmed diagnosis as defined in the World Health Organization (WHO) classification scheme

1. Follicular Lymphoma (FL) limited to Grade 1,2 or 3a or
2. Marginal Zone Lymphoma (MZL) including nodal, extranodal and splenic MZL
* Subjects that have had progression of disease or had no response to therapy after at least 2 prior systemic therapies for FL or MZL
* Age = 18
* At least one bi-dimensionally measurable nodal lesion > 1.5 cm in its longest diameter by computed tomography (CT) scan as defined by the Lugano Classification
* Adequate hematologic, renal and hepatic parameters at screening unless abnormal values are due to FL per Investigator assessment
* QT-interval corrected according to Fridericia's formula (QTcF) = 450 milliseconds (msec);
* Left ventricular ejection fraction (LVEF) = 45%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Histologically confirmed FL Grade 3b transformation from FL to an aggressive lymphoma
* Known lymphomatous involvement of the central nervous system
* Uncontrolled clinically significant illness
* Ongoing or history of drug-induced pneumonitis
* History of clinically significant cardiovascular abnormalities
* History of clinically significant GI conditions
* Known history of, or active HIV infection

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/03/2023
Sample size
Target
Accrual to date
Final
169
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment hospital [2] 0 0
The Perth Blood Institute - West Perth
Recruitment hospital [3] 0 0
Liverpool Hospital - Sydney
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
6005 - West Perth
Recruitment postcode(s) [3] 0 0
NSW2170 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
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United States of America
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Florida
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Illinois
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Indiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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Montana
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United States of America
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oregon
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Tennessee
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Texas
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Washington
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United States of America
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Wisconsin
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Austria
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Linz
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Austria
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Vienna
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Edegem
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France
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Bayonne
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France
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La Roche-Sur-Yon Cedex 9
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France
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Le Mans
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France
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Mulhouse
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Poitiers
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Villejuif
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Germany
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Rheinland-Pfalz
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Germany
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Stolberg
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Germany
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Halle
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Germany
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Munich
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Germany
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Münster
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Germany
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Ulm
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Aviano
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Bologna
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Genova
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Italy
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Meldola
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Italy
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Napoli
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Italy
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Ravenna
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Italy
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Rimini
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Italy
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Roma
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Italy
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Rome
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Italy
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Terni
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Italy
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Venice
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Korea, Republic of
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Busan
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Seoul
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Ulsan
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Auckland
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New Zealand
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Dunedin
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Poland
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Bydgoszcz
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Kraków
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Warszawa
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Wroclaw
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Lódz
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Pamplona
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Zaragoza
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Switzerland
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Bellinzona
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Taiwan
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Taichung
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Taiwan
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Tainan City
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Taiwan
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Tainan
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Taiwan
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Taipei City
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United Kingdom
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Denbighire
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United Kingdom
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Sutton
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United Kingdom
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UK
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United Kingdom
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Belfast
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United Kingdom
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Cornwell
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Liverpool
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United Kingdom
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London
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Manchester
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Norwich
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United Kingdom
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Oxford
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United Kingdom
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MEI Pharma, 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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03768505