A Phase 1 Dose Escalation Study of IPI-493

NCT00724425 | Terminated Phase 1

• 1 other identifier: IPI-493-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief Summary

IPI-493 is a potent inhibitor of heat shock protein 90 (Hsp90) and is orally bioavailable via a novel formulation.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (2)

• To determine the safety and maximum tolerated dose (MTD) of IPI 493

  ongoing

• To recommend a dosing regimen (dose and schedule) for subsequent studies of IPI 493

  ongoing

Interventions

IPI-493 DRUG

Capsules, Multiple Schedules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have pathologically confirmed advanced solid tumors
• Progressive disease for their advanced solid tumor
• Patients must be ≥18 years of age
• Performance status of 0 or 1.
• Not Pregnant by blood or urine test, and be willing to use adequate methods of birth control

You may not qualify if:

• Treatment with the following therapies within the specified time period:
• Any chemotherapy (other than nitrosoureas or mitomycin C), radiation therapy (other than whole brain irradiation \[WBI\]), surgery, hormonal therapy, or investigational therapy within 4 weeks of the start of IPI 493 administration
• Any tyrosine kinase inhibitor (e.g., erlotinib, imatinib) within 2 weeks
• Whole brain irradiation therapy within 3 months
• Stereotactic cranial radiosurgery (SRS) within 4 weeks
• Nitrosoureas or mitomycin C within 6 weeks
• Any known Hsp90 inhibitor
• Toxicities from prior therapies must have resolved to ≤ Grade 1 or baseline
• Concurrent administration of the medications or foods , which are known to inhibit or induce CYP3A activity to a clinically relevant degree, is not allowed.
• Concurrent treatment with any agent known to prolong the QTc interval
• Known human immunodeficiency virus (HIV) positivity.
• Inadequate hematologic function defined by absolute neutrophil count (ANC) \< 1,500 cells/mm3, a platelet count \< 100,000/mm3, and a hemoglobin \< 9.0 g/dL
• Inadequate hepatic function
• Inadequate renal function
• Sinus bradycardia

Sponsors & Collaborators

• Infinity Pharmaceuticals, Inc.: lead

Study Sites (5)

Premiere Oncology, Arizona

Scottsdale, Arizona, 85260, United States

Location

San Diego Pacific Oncology and Hematology Associates

Encinitas, California, 92024, United States

Location

Premiere Oncology, California

Santa Monica, California, 90404, United States

Location

Univeristy of Colorado Health Science Center

Aurora, Colorado, 80045, United States

Location

Mary Crowley Cancer Research Center

Dallas, Texas, 75201, United States

Location

MeSH Terms

Interventions

tanespimycin

Study Officials

• Robert Ross, MD

  Infinity Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (5)