Overview

This trial is active, not recruiting.

Condition hematologic malignancies
Treatment ipi-145 (duvelisib)
Phase phase 1
Sponsor Infinity Pharmaceuticals, Inc.
Start date October 2011
End date May 2015
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

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Eligibility Criteria

Male or female 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 August 2016.
Information provided to ClinicalTrials.gov by Infinity Pharmaceuticals, Inc..