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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:
Information provided by (Responsible Party):
Verastem, Inc.
ClinicalTrials.gov Identifier:
NCT01476657
First received: November 17, 2011
Last updated: February 21, 2017
Last verified: August 2016
  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: No masking
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)
Intervention Details:
    Drug: IPI-145 (duvelisib)
    Oral Twice A Day (BID) Dosing
  Eligibility

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
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 ClinicalTrials.gov identifier: 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
Study First Received: November 17, 2011
Last Updated: February 21, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Verastem, Inc.:
Phase 1

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 26, 2017