- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724425
A Phase 1 Dose Escalation Study of IPI-493
April 14, 2015 updated by: Infinity Pharmaceuticals, Inc.
A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of IPI-493 Orally Administered to Patients With Advanced Malignancies
IPI-493 is a potent inhibitor of heat shock protein 90 (Hsp90) and is orally bioavailable via a novel formulation.
Study Overview
Detailed Description
Hsp90 controls the proper folding, function, and stability of various "client" proteins within cells.
Many of the clients of Hsp90 (such as Akt, Bcr-Abl, EGFR, Flt-3, c-Kit and PDGFR α) are oncoproteins or important cell-signaling proteins, and therefore are critical for tumor cell growth and survival.
Inhibition of Hsp90 results in degradation of these proteins, which abrogates growth and survival signaling and leads to tumor cell death.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85260
- Premiere Oncology, Arizona
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California
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Encinitas, California, United States, 92024
- San Diego Pacific Oncology and Hematology Associates
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Santa Monica, California, United States, 90404
- Premiere Oncology, California
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Colorado
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Aurora, Colorado, United States, 80045
- Univeristy of Colorado Health Science Center
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Texas
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Dallas, Texas, United States, 75201
- Mary Crowley Cancer Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
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:
- Have been on a stable dose of anticoagulation for <1 month
- Have had a Grade 2, 3 or 4 hemorrhage in the past month
Are experiencing continued symptoms from their venous thromboembolic event
- Patients who have had a venous thromboembolic event but do not meet any of the above three criteria are eligible for participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the safety and maximum tolerated dose (MTD) of IPI 493
Time Frame: ongoing
|
ongoing
|
To recommend a dosing regimen (dose and schedule) for subsequent studies of IPI 493
Time Frame: ongoing
|
ongoing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert Ross, MD, Infinity Pharmaceuticals, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 28, 2008
First Posted (Estimate)
July 29, 2008
Study Record Updates
Last Update Posted (Estimate)
April 15, 2015
Last Update Submitted That Met QC Criteria
April 14, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPI-493-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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