A Phase 1 Study of IPI-145 in Patients With Advanced Hematologic Malignancies

This study is currently recruiting participants.

Verified December 2012 by Infinity Pharmaceuticals, Inc.

Sponsor:

Information provided by (Responsible Party):

Infinity Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT01476657

First received: November 17, 2011

Last updated: December 5, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2011

Last Updated Date

December 5, 2012

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and Tolerability [ Time Frame: At least 28 days (1 Cycle) ] [ Designated as safety issue: Yes ]

To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01476657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase 1 Study of IPI-145 in Patients With Advanced Hematologic Malignancies

Official Title ^ICMJE

A Phase 1 Study of IPI-145 in Patients With Advanced Hematologic Malignancies

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hematologic Malignancies

Intervention ^ICMJE

Drug: IPI-145

Oral Twice A Day (BID) Dosing

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

May 2014

Estimated Primary Completion Date

April 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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;
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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jennifer Sweeney

617-453-1225

jennifer.sweeney@infi.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01476657

Other Study ID Numbers ^ICMJE

IPI-145-02

Has Data Monitoring Committee

Responsible Party

Infinity Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

Infinity Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Patrick Kelly, MD

Infinity Pharmaceuticals, Inc.

Information Provided By

Infinity Pharmaceuticals, Inc.

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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