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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2017-01-31

Brief Summary

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The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.

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Detailed Description

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Conditions

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Hematologic Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IPI-145 (duvelisib)

Intervention Type DRUG

Oral Twice A Day (BID) Dosing

Interventions

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IPI-145 (duvelisib)

Oral Twice A Day (BID) Dosing

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No