A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

Sponsor

SecuraBio (Industry)

Overall Status

Terminated

CT.gov ID

NCT01476657

Collaborator

(none)

210

Enrollment

Locations

Arm

Duration (Months)

52.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: IPI-145 (duvelisib)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPI-145 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) Oral Twice A Day (BID) Dosing

Arm

Intervention/Treatment

Experimental: IPI-145

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)

Oral Twice A Day (BID) Dosing

Outcome Measures

Primary Outcome Measures

Safety and Tolerability [At least 28 days (1 Cycle)]
To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	New York	New York	United States	10065
2	Columbus	Ohio	United States	43210
3	Nashville	Tennessee	United States	37203
4	Houston	Texas	United States	77030

Sponsors and Collaborators

SecuraBio

Investigators

Study Chair: Hagop Youssoufian, MD, Verastem, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

SecuraBio

ClinicalTrials.gov Identifier:

NCT01476657

Other Study ID Numbers:

IPI-145-02

First Posted:

Nov 22, 2011

Last Update Posted:

Mar 17, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by SecuraBio

Phase 1

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Mar 17, 2021