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

This study has been terminated.
(The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01476657
First Posted: November 22, 2011
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Verastem, Inc.
  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 (duvelisib) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies

Further study details as provided by Verastem, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: At least 28 days (1 Cycle) ]
    To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.


Enrollment: 210
Study Start Date: October 2011
Study Completion Date: January 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-145
IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles.
Drug: IPI-145 (duvelisib)
Oral Twice A Day (BID) Dosing

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01476657


Locations
United States, New York
New York, New York, United States, 10065
United States, Ohio
Columbus, Ohio, United States, 43210
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Verastem, Inc.
Investigators
Study Chair: Hagop Youssoufian, MD Verastem, Inc.
  More Information

Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT01476657     History of Changes
Other Study ID Numbers: IPI-145-02
First Submitted: November 17, 2011
First Posted: November 22, 2011
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Verastem, Inc.:
Phase 1

Additional relevant MeSH terms:
Neoplasms