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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01476657
• Other study ID #: IPI-145-02
• Status: Terminated
• Phase: Phase 1
• Start date: October 2011
• Est. completion date: January 2017

Study information

• Verified date: March 2021
• Source: SecuraBio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 210
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

Drug:
• IPI-145 (duvelisib)
Oral Twice A Day (BID) Dosing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
SecuraBio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.	At least 28 days (1 Cycle)