Back to resultsA Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
Primary Purpose
Hematologic Malignancies
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IPI-145 (duvelisib)
Sponsored by
About this trial
This is an interventional treatment trial for Hematologic Malignancies focused on measuring Phase 1
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age;
- Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients;
- An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
Exclusion Criteria:
- Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase);
- Patients with overt leptomeningeal leukemia or CNS lymphoma;
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x ULN;
- Inadequate renal function defined by serum creatinine > 1.5 x ULN
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPI-145
Arm Description
IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles.
Outcomes
Primary Outcome Measures
Safety and Tolerability
To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01476657
Brief Title
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
Official Title
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SecuraBio
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Phase 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPI-145
Arm Type
Experimental
Arm Description
IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles.
Intervention Type
Drug
Intervention Name(s)
IPI-145 (duvelisib)
Intervention Description
Oral Twice A Day (BID) Dosing
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.
Time Frame
At least 28 days (1 Cycle)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 years of age;
Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients;
An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
Exclusion Criteria:
Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase);
Patients with overt leptomeningeal leukemia or CNS lymphoma;
Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x ULN;
Inadequate renal function defined by serum creatinine > 1.5 x ULN
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hagop Youssoufian, MD
Organizational Affiliation
Verastem, Inc.
Official's Role
Study Chair
Facility Information:
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29233821
Citation
Horwitz SM, Koch R, Porcu P, Oki Y, Moskowitz A, Perez M, Myskowski P, Officer A, Jaffe JD, Morrow SN, Allen K, Douglas M, Stern H, Sweeney J, Kelly P, Kelly V, Aster JC, Weaver D, Foss FM, Weinstock DM. Activity of the PI3K-delta,gamma inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma. Blood. 2018 Feb 22;131(8):888-898. doi: 10.1182/blood-2017-08-802470. Epub 2017 Dec 12.
Results Reference
derived
PubMed Identifier
29191916
Citation
Flinn IW, O'Brien S, Kahl B, Patel M, Oki Y, Foss FF, Porcu P, Jones J, Burger JA, Jain N, Kelly VM, Allen K, Douglas M, Sweeney J, Kelly P, Horwitz S. Duvelisib, a novel oral dual inhibitor of PI3K-delta,gamma, is clinically active in advanced hematologic malignancies. Blood. 2018 Feb 22;131(8):877-887. doi: 10.1182/blood-2017-05-786566. Epub 2017 Nov 30.
Results Reference
derived
PubMed Identifier
28017967
Citation
Patel VM, Balakrishnan K, Douglas M, Tibbitts T, Xu EY, Kutok JL, Ayers M, Sarkar A, Guerrieri R, Wierda WG, O'Brien S, Jain N, Stern HM, Gandhi V. Duvelisib treatment is associated with altered expression of apoptotic regulators that helps in sensitization of chronic lymphocytic leukemia cells to venetoclax (ABT-199). Leukemia. 2017 Sep;31(9):1872-1881. doi: 10.1038/leu.2016.382. Epub 2016 Dec 26.
Results Reference
derived
Learn more about this trial
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
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