A Phase 1 Dose Escalation Study of IPI-493

Stopped early · Phase 1

Conditions studied: Advanced Malignancies

In brief

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

Key facts

Study ID

NCT00724425

Run by

Infinity Pharmaceuticals, Inc.

People needed

53

Starts

2008-07-01

Expected to finish

2011-07-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Baseline QTcF > 450 msec in males; QTcF > 470 msec in females.
• Presence of left bundle branch block (LBBB), right bundle branch block (RBBB) if accompanied by left anterior hemiblock, bifascicular block or 3rd degree heart block. This does not include patients with a history of these events with adequate control by pacemaker.
• Patients who have received > 450 mg/m2 of any anthracycline during prior chemotherapy must have a baseline left ventricular ejection fraction (LVEF) > 40%.
• Active keratitis or keratoconjunctivitis.
• Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
• Patients with a clinically active brain metastasis
• Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
• Significant co-morbid condition or disease which in the judgment of the Investigator would place the patient at undue risk or interfere with the study. Examples include, but are not limited to cirrhotic liver disease, sepsis, and other conditions.
• Women who are pregnant or lactating.
• Patients who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and meet any of the following criteria are excluded:

Where it is running

• Premiere Oncology, Arizona — Scottsdale, Arizona, United States
• San Diego Pacific Oncology and Hematology Associates — Encinitas, California, United States
• Premiere Oncology, California — Santa Monica, California, United States
• Univeristy of Colorado Health Science Center — Aurora, Colorado, United States
• Mary Crowley Cancer Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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