A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
NCT ID: NCT01310816
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
105 participants
INTERVENTIONAL
2011-02-28
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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IPI-926
IPI-926
IPI-926
Oral
Sugar Pill
Placebo Arm, sugar pill
Placebo Arm
oral placebo
Interventions
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IPI-926
Oral
Placebo Arm
oral placebo
Eligibility Criteria
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Inclusion Criteria
* Pathologically diagnosed conventional chondrosarcoma. Patients must have tumor sample(s) available or provide tumor samples from a new biopsy
* Metastasis to at least 1 location or locally advanced disease that is deemed unresectable by a surgeon
* At least 1 radiologically measurable target lesion per RECIST 1.1.
* Patients must have documented radiographic progression of disease within the 6-month period prior to screening. (MRI or CT Scan)
* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.
* Life expectancy of at least 3 months
* All women of child-bearing potential (WCBP), all sexually active male patients, and all partners of patients must agree to use adequate methods of birth control throughout the study and for 30 days after the last dose of study drug.
* Ability to adhere to the study visit schedule and all protocol requirements.
* Voluntarily signed an informed consent form.
Exclusion Criteria
* Systemic anti-cancer therapy within 21 days prior to the first dose of study drug, or radiotherapy within 14 days prior to the first dose of study drug.
* Prior treatment with a Hedgehog pathway inhibitor
* Medically significant surgical procedures or significant traumatic injury within 28 days before Day 1.
* Inadequate hematologic function defined by:
* Hemoglobin \<8.0 g/dL (80 g/L) (may be increased to this level with transfusion as long as there is no evidence of active bleeding).
* Inadequate hepatic function defined by:
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 x upper limit of normal (ULN).
* Total bilirubin \>1.5 x ULN (with the exception of patients with Gilbert's disease).
* Cirrhotic liver disease, ongoing alcohol abuse, or known chronic active or acute hepatitis.
* Inadequate renal function defined by serum creatinine \>1.5 x ULN
* Patients with a history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months.
* Presence of active infection or systemic use of antibiotics within 72 hours of treatment.
* 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 sepsis and recent significant traumatic injury.
* Known human immunodeficiency virus (HIV) positivity.
* Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 or placebo capsules.
* Pregnant or lactating women.
* Current administration of the medications or foods which are known to be moderate or strong inhibitors of CYP3A4 activity
18 Years
ALL
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pedro Santabarbara, MD
Role: STUDY_CHAIR
Infinity Pharmaceuticals, Inc.
Locations
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(TGen) Translational Genomics Research Institute
Scottsdale, Arizona, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University in St. Louis
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Sydney Cancer Centre
Camperdown, New South Wales, Australia
Monash Medical Centre
East Bentleigh, Victoria, Australia
Medizinische Universität Wien
Vienna, Vienna, Austria
Mount Sinai Hospital
Toronto, Ontario, Canada
Centre Léon Bérard, Service d'Oncologie Médicale
Lyon, Auvergne-Rhône-Alpes, France
Centre René Gauducheau
Saint-Herblain, Pays de la Loire Region, France
Institut de Cancérologie Gustave Roussy
Villejuif, Île-de-France Region, France
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
Helios Klinikum Bad Saarow
Bad Saarow, Brandenburg, Germany
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany
IRCCS Istituto Ortopedico Rizzoli
Bologna, Bologna, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Milano, Italy
Leids Unversitair Medisch Centrum
Leiden, South Holland, Netherlands
Radiumhospitalet
Oslo, , Norway
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warsaw, Masovian Voivodeship, Poland
SI Russian Oncological Research Center
Moscow, Moscow, Russia
Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies
Moscow, Moscow, Russia
Skånes Universitetssjukhus
Lund, Skåne County, Sweden
Royal Orthopaedic Hospital
Birmingham, England, United Kingdom
University College Hospital
London, England, United Kingdom
Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Countries
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Other Identifiers
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IPI-926-04
Identifier Type: -
Identifier Source: org_study_id