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

Phase 1

Terminated

• Conditions: Hematologic Malignancies
• Interventions: Drug: IPI-145 (duvelisib)

• Registration Number: NCT01476657
• Lead Sponsor: SecuraBio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-22
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPI-145	IPI-145 (duvelisib)	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.

Primary Outcome Measures

Name	Time	Method
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.