Dose Escalation of IPI-493 in Hematologic Malignancies

• Sponsor: Infinity Pharmaceuticals, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01193491
• Collaborator: (none)
• Enrollment: 4
• Locations: 3
• Arm: 1
• Duration (Months): 13
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: IPI-493	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPI-493	Drug: IPI-493; Capsules, ascending dose, multiple schedules; Other Names: HSP-90 Geldanamycin

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Evaluation of Efficacy Endpoints [1 year]

2. Evaluation of Efficacy Endpoints [1 year]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins Sidney Kimmel Cancer Center	Baltimore	Maryland	United States	21201
2	Weill Cornell Cancer Center	New York	New York	United States	10065
3	M.D. Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Infinity Pharmaceuticals, Inc.

Investigators

• Study Director: Robert Ross, M.D., Infinity Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Infinity Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01193491
• Other Study ID Numbers: IPI-493-02
• First Posted: Sep 2, 2010
• Last Update Posted: Apr 15, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Infinity Pharmaceuticals, Inc.: Phase 1; AML; CML; MPD; Client Proteins; Hsp90
• Additional relevant MeSH terms: Neoplasms; Hematologic Neoplasms; Geldanamycin

Study Results

No Results Posted as of Apr 15, 2015