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Status:

TERMINATED

A Phase 1 Dose Escalation Study of IPI-493

Lead Sponsor:

Infinity Pharmaceuticals, Inc.

Conditions:

Advanced Malignancies

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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

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 oncoprotei...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2011

Estimated Enrollment :

53 Patients enrolled

Trial Details

Trial ID

NCT00724425

Start Date

July 1 2008

End Date

July 1 2011

Last Update

April 15 2015

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Premiere Oncology, Arizona

Scottsdale, Arizona, United States, 85260

2

San Diego Pacific Oncology and Hematology Associates

Encinitas, California, United States, 92024

3

Premiere Oncology, California

Santa Monica, California, United States, 90404

4

Univeristy of Colorado Health Science Center

Aurora, Colorado, United States, 80045