Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc. Identifier:
First received: November 17, 2011
Last updated: February 17, 2015
Last verified: February 2015

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 (duvelisib)
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

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.

Enrollment: 210
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: IPI-145 (duvelisib)
    Oral Twice A Day (BID) Dosing

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01476657

United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Sarasota, Florida, United States, 34232
United States, New York
New York, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Study Director: Tess Schmalbach, MD Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc. Identifier: NCT01476657     History of Changes
Other Study ID Numbers: IPI-145-02
Study First Received: November 17, 2011
Last Updated: February 17, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
Phase 1

Additional relevant MeSH terms:
Neoplasms processed this record on February 27, 2015