NCT01476657

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

5.2 years

First QC Date

November 17, 2011

Last Update Submit

March 15, 2021

Conditions

Hematologic Malignancies

Keywords

Phase 1

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.

    At least 28 days (1 Cycle)

Study Arms (1)

IPI-145

EXPERIMENTAL

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.

Drug: IPI-145 (duvelisib)

Interventions

IPI-145 (duvelisib)DRUG

Oral Twice A Day (BID) Dosing

IPI-145

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Columbus, Ohio, 43210, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

    PMID: 29233821DERIVED

  • 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.

    PMID: 29191916DERIVED

  • 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.

    PMID: 28017967DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Hagop Youssoufian, MD

    Verastem, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 22, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

US(4)