Duvelisib

Generic Name: Duvelisib

Brand Names: Copiktra

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₁₇ClN_₆O

CAS Number: 1201438-56-3

Unique Ingredient Identifier: 610V23S0JI

Background: Duvelisib, also known as IPI-145 and INK-1197, is a small-molecule inhibitor of phosphoinositide-3 kinases that was designed initially to prove that simultaneous inhibition of the isoforms delta and gamma can produce a broad adaptative and innate immune cell inhibitory activity. All the work around duvelisib showed that this agent is a potent inhibitor of both forms. Duvelisib was developed by Verastem, Inc and FDA approved on September 24, 2018.

Indication: Duvelisib is indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have trialed at least two prior therapies.

Associated Conditions: Refractory Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia (CLL), Relapsed Small Lymphocytic Lymphoma

Clinical Trials

A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

Phase 1

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: Duvelisib
Biological: Pembrolizumab

First Posted Date: 2019-12-10

Last Posted Date: 2023-09-21

Lead Sponsor: SecuraBio

Target Recruit Count: 2

Registration Number: NCT04193293

Locations: 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma

Phase 2

Completed

Conditions: Indolent Non-Hodgkin Lymphoma

Interventions: Drug: Duvelisib

First Posted Date: 2019-07-30

Last Posted Date: 2024-02-06

Lead Sponsor: SecuraBio

Target Recruit Count: 102

Registration Number: NCT04038359

Locations: 🇵🇱
Pratia Onkologia Katowice, Katowice, Poland
🇮🇹
Ospedale di Circolo, PO Varese, AO Ospedale di Circolo e Fondazione Macchi, Varese, Italy
🇩🇪
Universitaetsklinikum Bonn AöR, Bonn, Germany

and more 25 locations

Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Active, not recruiting

Conditions: Recurrent Small Lymphocytic Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Refractory Chronic Lymphocytic Leukemia
Refractory Small Lymphocytic Lymphoma

Interventions: Drug: Duvelisib

First Posted Date: 2019-05-23

Last Posted Date: 2025-01-13

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 15

Registration Number: NCT03961672

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma

Phase 1

Completed

Conditions: Recurrent Diffuse Large B-Cell Lymphoma
Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma
Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Refractory Diffuse Large B-Cell Lymphoma
Small Lymphocytic Lymphoma
Richter Syndrome
Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions: Drug: Duvelisib
Biological: Nivolumab

First Posted Date: 2019-03-27

Last Posted Date: 2024-05-02

Lead Sponsor: David Bond, MD

Target Recruit Count: 7

Registration Number: NCT03892044

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Duvelisib and Venetoclax in Relapsed or Refractory CLL or SLL or RS

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Richter Syndrome

Interventions: Drug: Duvelisib
Drug: Venetoclax

First Posted Date: 2018-05-23

Last Posted Date: 2025-01-07

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 67

Registration Number: NCT03534323

Locations: 🇺🇸
Northern Light Eastern Maine Medical Center, Brewer, Maine, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Boston Medical Center, Boston, Massachusetts, United States

and more 4 locations

A Study of Duvelisib in Participants With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Phase 2

Completed

Conditions: Peripheral T-cell Lymphoma

Interventions: Drug: Duvelisib

First Posted Date: 2017-12-13

Last Posted Date: 2025-03-07

Lead Sponsor: SecuraBio

Target Recruit Count: 156

Registration Number: NCT03372057

Locations: 🇯🇵
Japanese Site 7, Niigata, Japan
🇯🇵
Japanese Site 1, Okayama, Japan
🇯🇵
Japanese Site 8, Fukuoka, Japan

and more 33 locations

Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma

Phase 2

Withdrawn

Conditions: Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia

Interventions: Drug: Duvelisib

First Posted Date: 2017-12-12

Last Posted Date: 2023-02-28

Lead Sponsor: SecuraBio

Registration Number: NCT03370185

Locations: 🇺🇸
St. Vincent Frontier Cancer Center, Billings, Montana, United States
🇺🇸
Ingalls Memorial Hospital, Harvey, Illinois, United States
🇺🇸
Genesis Cancer Center, Hot Springs, Arkansas, United States

and more 5 locations

Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas

Phase 1

Active, not recruiting

Conditions: Lymphoma
Relapsed/Refractory T-cell Lymphomas

Interventions: Drug: Romidepsin
Drug: Bortezomib
Drug: duvelisib

First Posted Date: 2016-05-26

Last Posted Date: 2024-07-03

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 114

Registration Number: NCT02783625

Locations: 🇺🇸
Stanford University Medical Center, Stanford, California, United States
🇺🇸
University of Washington School of Medicine in St. Louis, Saint Louis, Missouri, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

and more 8 locations

A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)

Phase 2

Completed

Conditions: Hematologic Malignancy

Interventions: Drug: Duvelisib

First Posted Date: 2016-03-17

Last Posted Date: 2023-09-11

Lead Sponsor: SecuraBio

Target Recruit Count: 19

Registration Number: NCT02711852

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States
🇮🇹
Azienda Ospedaliera Santa Maria di Terni/SC Oncoematologia, Terni, Umbria, Italy

A Study of Duvelisib and Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Indolent or Aggressive Non-Hodgkin Lymphoma, Who Have Not Previously Received a Bcl-2 or PI3K Inhibitor

Phase 1

Withdrawn

Conditions: Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Small Lymphocytic Lymphoma

Interventions: Drug: Duvelisib
Drug: Venetoclax

First Posted Date: 2015-12-29

Last Posted Date: 2016-07-26

Lead Sponsor: AbbVie

Registration Number: NCT02640833

Locations: 🇺🇸
Site Reference ID/Investigator# 148562, Harvey, Illinois, United States
🇺🇸
Site Reference ID/Investigator# 147922, Chicago, Illinois, United States
🇺🇸
Site Reference ID/Investigator# 145674, Baltimore, Maryland, United States

and more 7 locations

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