Overview

This trial has been terminated.

Condition hematologic malignancies
Treatment ipi-145 (duvelisib)
Phase phase 1
Sponsor Verastem, Inc.
Start date October 2011
End date December 2016
Trial size 210 participants
Trial identifier NCT01476657, IPI-145-02

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking

Primary Outcomes

Measure
Safety and Tolerability
time frame: At least 28 days (1 Cycle)

Eligibility Criteria

All participants at least 18 years old.

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

Additional Information

Official title A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Verastem, Inc..