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

Phase 1
18 Years
Open (Enrolling)
Hematologic Malignancies

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Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Safety and Tolerability

Outcome Description:

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

Outcome Time Frame:

At least 28 days (1 Cycle)

Safety Issue:


Principal Investigator

Patrick Kelly, MD

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

October 2014

Related Keywords:

  • Hematologic Malignancies
  • Phase 1
  • Neoplasms
  • Hematologic Neoplasms



New Britain, Connecticut  06052
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Milwaukee, Wisconsin