NCT01193491

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

June 28, 2010

Last Update Submit

April 14, 2015

Conditions

Hematologic Malignancies

Keywords

Phase 1AMLCMLMPDClient ProteinsHsp90

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Secondary Outcomes (2)

  • Evaluation of Efficacy Endpoints

    1 year

  • Evaluation of Efficacy Endpoints

    1 year

Study Arms (1)

IPI-493

EXPERIMENTAL
Drug: IPI-493

Interventions

IPI-493DRUG

Capsules, ascending dose, multiple schedules

Also known as: HSP-90, Geldanamycin
IPI-493

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>/=18 years old
  • ECOG 0-1
  • confirmed hematological malignancy
  • refractory to available therapy or for which no therapy is available
  • adequate hepatic, renal function

You may not qualify if:

  • active CNS malignancy
  • prolonged QT interval
  • significant GI/liver disease
  • other serious concurrent illness or medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Johns Hopkins Sidney Kimmel Cancer Center

Baltimore, Maryland, 21201, United States

Location

Weill Cornell Cancer Center

New York, New York, 10065, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

tanespimycinHSP90 Heat-Shock Proteinsgeldanamycin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heat-Shock ProteinsMolecular ChaperonesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Robert Ross, M.D.

    Infinity Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2010

First Posted

September 2, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

US(3)