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

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Status and phase: Terminated; Phase 1

Conditions: Hematologic Malignancies

Treatments: Drug: IPI-145 (duvelisib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01476657

IPI-145-02

Details and patient eligibility

About

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

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

IPI-145

Experimental group

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.

Treatment:

Drug: IPI-145 (duvelisib)