Dose Escalation of IPI-493 in Hematologic Malignancies

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01193491

Enrollment

Registered

2010-09-02

Start date

2010-06-30

Completion date

2011-07-31

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancies

Keywords

Phase 1, AML, CML, MPD, Client Proteins, Hsp90

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.

Interventions

DRUGIPI-493

Capsules, ascending dose, multiple schedules

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of Safety Endpoints	1 year	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

Measure	Time frame
Evaluation of Efficacy Endpoints	1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026