Dose Escalation of IPI-493 in Hematologic Malignancies

Hematologic Malignancies Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01193491
• Other study ID #: IPI-493-02
• Status: Terminated
• Phase: Phase 1
• First received: June 28, 2010
• Last updated: April 14, 2015
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: April 2015
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hematologic Malignancies
• Neoplasms

Intervention

Drug:
• IPI-493
Capsules, ascending dose, multiple schedules

Locations

Country	Name	City	State
United States	Johns Hopkins Sidney Kimmel Cancer Center	Baltimore	Maryland
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Weill Cornell Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Evaluation of Efficacy Endpoints		1 year	No
Secondary	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)	1 year	No