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A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety and Tolerability of IPI-493 in Patients Experiencing Advanced Hematologic Malignancies With Client Proteins of Hsp90


Phase 1
18 Years
N/A
Not Enrolling
Both
Hematologic Malignancies

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Trial Information

A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety and Tolerability of IPI-493 in Patients Experiencing Advanced Hematologic Malignancies With Client Proteins of Hsp90


Inclusion Criteria:



- >/=18 years old

- ECOG 0-1

- confirmed hematological malignancy

- refractory to available therapy or for which no therapy is available

- adequate hepatic, renal function

Exclusion Criteria:

- active CNS malignancy

- prolonged QT interval

- significant GI/liver disease

- other serious concurrent illness or medical condition

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluation of Safety Endpoints

Outcome Description:

Safety Endpoints The incidence of reported adverse events (AEs), serious adverse events (SAEs), concomitant medication use, laboratory test results, electrocardiogram (ECG) results, Eastern Cooperative Oncology Group (ECOG) performance status results, and vital sign results Maximum tolerated dose, defined as the dose level below the dose at which ≥33% of patients experience a dose limiting toxicity (DLT) Pharmacodynamic Endpoints

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Robert Ross, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IPI-493-02

NCT ID:

NCT01193491

Start Date:

June 2010

Completion Date:

July 2011

Related Keywords:

  • Hematologic Malignancies
  • Phase 1
  • AML
  • CML
  • MPD
  • Client Proteins
  • Hsp90
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

M.D. Anderson Cancer CenterHouston, Texas  77030
Weill Cornell Cancer CenterNew York, New York  10065
Johns Hopkins Sidney Kimmel Cancer CenterBaltimore, Maryland  21201