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Dose Escalation of IPI-493 in Hematologic Malignancies

Primary Purpose

Hematologic Malignancies

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IPI-493
Sponsored by
Infinity Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancies focused on measuring Phase 1, AML, CML, MPD, Client Proteins, Hsp90

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Sidney Kimmel Cancer Center
  • Weill Cornell Cancer Center
  • M.D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IPI-493

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of Safety Endpoints
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

Secondary Outcome Measures

Evaluation of Efficacy Endpoints
Evaluation of Efficacy Endpoints
Hematologic disease-specific outcomes for response including but not limited to complete hematologic response (CHR) and partial hematologic response (PHR) Plasma concentrations of IPI-493 (and IPI-493 metabolites, if applicable)

Full Information

First Posted
June 28, 2010
Last Updated
April 14, 2015
Sponsor
Infinity Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01193491
Brief Title
Dose Escalation of IPI-493 in Hematologic Malignancies
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Drug exposure of retaspimycin HCl was superior to IPI-493, Infinity will focus on Retaspimycin HCL
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infinity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety, determine the maximum tolerated dose (MTD) and schedule of IPI-493 in patients with hematologic malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancies
Keywords
Phase 1, AML, CML, MPD, Client Proteins, Hsp90

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPI-493
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IPI-493
Other Intervention Name(s)
HSP-90, Geldanamycin
Intervention Description
Capsules, ascending dose, multiple schedules
Primary Outcome Measure Information:
Title
Evaluation of Safety Endpoints
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of Efficacy Endpoints
Time Frame
1 year
Title
Evaluation of Efficacy Endpoints
Description
Hematologic disease-specific outcomes for response including but not limited to complete hematologic response (CHR) and partial hematologic response (PHR) Plasma concentrations of IPI-493 (and IPI-493 metabolites, if applicable)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ross, M.D.
Organizational Affiliation
Infinity Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Weill Cornell Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dose Escalation of IPI-493 in Hematologic Malignancies

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