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

Purpose

The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.

Condition	Intervention	Phase
Hematologic Malignancies	Drug: IPI-145	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1 Study of IPI-145 in Patients With Advanced Hematologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:

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.

Estimated Enrollment:	200
Study Start Date:	October 2011
Estimated Study Completion Date:	May 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Intervention Details:

Oral Twice A Day (BID) Dosing

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476657

Contacts

Contact: Jennifer Sweeney

617-453-1225

jennifer.sweeney@infi.com

Locations

United States, Connecticut
	Recruiting
New Haven, Connecticut, United States
United States, Florida
	Recruiting
Sarasota, Florida, United States, 34232
Contact 877-691-7274 asksarah@scresearch.net
United States, New York
	Recruiting
New York, New York, United States
United States, Ohio
	Not yet recruiting
Columbus, Ohio, United States
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States, 37203
Contact 877-691-7274 asksarah@scresearch.net
United States, Texas
	Recruiting
Houston, Texas, United States
United States, Wisconsin
	Recruiting
Madison, Wisconsin, United States

Sponsors and Collaborators

Infinity Pharmaceuticals, Inc.

Investigators

Study Director:

Patrick Kelly, MD

Infinity Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01476657 History of Changes
Other Study ID Numbers:	IPI-145-02
Study First Received:	November 17, 2011
Last Updated:	December 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:

Phase 1

Additional relevant MeSH terms:

Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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