Zandelisib

Generic Name: Zandelisib

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₃₈F_₂N_₈O

CAS Number: 1401436-95-0

Unique Ingredient Identifier: 8Z28M5SX0X

Clinical Trials

Zandelisib + Tazemetostat in R/R Follicular Lymphoma

Phase 1

Withdrawn

Conditions: Relapsed Follicular Lymphoma
Refractory Follicular Lymphoma

Interventions: Drug: TAZEMETOSTAT
Drug: Zandelisib

First Posted Date: 2022-11-03

Last Posted Date: 2023-07-07

Lead Sponsor: Jacob Soumerai, MD

Registration Number: NCT05604417

Rituximab Plus Venetoclax in Combination With Zandelisib in Subjects With CLL

Phase 2

Withdrawn

Conditions: CLL

Interventions: Drug: Zandelisib
Drug: Rituximab
Drug: Venetoclax

First Posted Date: 2022-01-26

Last Posted Date: 2023-03-16

Lead Sponsor: MEI Pharma, Inc.

Registration Number: NCT05209308

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Stony Brook University, Stony Brook, New York, United States
🇺🇸
OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States

and more 1 locations

Phase 3 Study of Zandelisib (ME-401) in Combination With Rituximab in Patients With iNHL - (COASTAL)

Phase 3

Terminated

Conditions: Follicular Lymphoma (FL)
Marginal Zone Lymphoma
Non Hodgkin Lymphoma

Interventions: Drug: Rituximab
Drug: Zandelisib
Drug: Bendamustine
Drug: CHOP

First Posted Date: 2021-02-09

Last Posted Date: 2024-11-04

Lead Sponsor: MEI Pharma, Inc.

Target Recruit Count: 82

Registration Number: NCT04745832

Locations: 🇺🇸
Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center, Springfield, Missouri, United States
🇺🇸
Community Cancer Trials of Utah, Ogden, Utah, United States
🇨🇦
Centre intégré universitaire de santé et de services sociaux de l'Estrie, Sherbrooke, Quebec, Canada

and more 135 locations

Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma (NHL)

Phase 2

Active, not recruiting

Conditions: Indolent B-cell Non-Hodgkin's Lymphoma

Interventions: Drug: ME-401

First Posted Date: 2020-08-31

Last Posted Date: 2024-07-17

Lead Sponsor: Kyowa Kirin Co., Ltd.

Target Recruit Count: 61

Registration Number: NCT04533581

Locations: 🇯🇵
National Hospital Organization Nagoya Medical Center, Nagoya, Aichi, Japan
🇯🇵
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
🇯🇵
Jichi Medical University Hospital, Shimotsuke, Tochigi, Japan

and more 27 locations

ME-401 and R-CHOP in Newly Diagnosed Diffuse Large B-Cell Lymphoma

Phase 1

Terminated

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: ME-401
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone

First Posted Date: 2020-08-18

Last Posted Date: 2025-02-07

Lead Sponsor: Deepa Jagadeesh

Target Recruit Count: 13

Registration Number: NCT04517435

Locations: 🇺🇸
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Study of ME-401 in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Phase 1

Active, not recruiting

Conditions: Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma

Interventions: Drug: ME-401

First Posted Date: 2019-06-13

Last Posted Date: 2024-07-17

Lead Sponsor: Kyowa Kirin Co., Ltd.

Target Recruit Count: 14

Registration Number: NCT03985189

Locations: 🇯🇵
The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
🇯🇵
Aomori Prefectural Central Hospital, Aomori, Japan
🇯🇵
Kyushu University Hospital, Fukuoka, Japan

and more 6 locations

Zandelisib (ME-401) in Subjects With Follicular Lymphoma or Marginal Zone Lymphoma After Failure of Two or More Prior Therapies (TIDAL)

Phase 2

Terminated

Conditions: Non Hodgkin Lymphoma
Follicular Lymphoma (FL)
Marginal Zone Lymphoma

Interventions: Drug: Zandelisib (ME-401)

First Posted Date: 2018-12-07

Last Posted Date: 2024-12-31

Lead Sponsor: MEI Pharma, Inc.

Target Recruit Count: 169

Registration Number: NCT03768505

Locations: 🇫🇷
CHD Vendee, Onco-hematologie, La Roche-Sur-Yon Cedex 9, France
🇺🇸
Tower Hematology Oncology, Beverly Hills, California, United States
🇺🇸
Memorial Sloan Kettering, Uniondale, New York, United States

and more 104 locations

A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma

Phase 1

Terminated

Conditions: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Marginal Zone B Cell Lymphoma
High Grade Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma (MCL)
Follicular Lymphoma (FL)
Diffuse Large B-cell Lymphoma (DLBCL)

Interventions: Drug: ME-401
Drug: Rituximab
Drug: Zanubrutinib

First Posted Date: 2016-09-26

Last Posted Date: 2023-05-09

Lead Sponsor: MEI Pharma, Inc.

Target Recruit Count: 97

Registration Number: NCT02914938

Locations: 🇺🇸
Swedish Cancer Institute, Issaquah, Washington, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Compassionate Care, Corona, California, United States

and more 15 locations

Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Various Formulations and Doses of PWT-143

Phase 1

Completed

Conditions: Malignancies

Interventions: Drug: PWT-143

First Posted Date: 2015-08-13

Last Posted Date: 2017-08-29

Lead Sponsor: MEI Pharma, Inc.

Target Recruit Count: 35

Registration Number: NCT02521389

Locations: 🇬🇧
Quotient Clinical, Ruddington, Nottingham, United Kingdom

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