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A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01310816
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : December 5, 2013
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.

Brief Summary:
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.

Condition or disease Intervention/treatment Phase
Conventional Chondrosarcoma Drug: IPI-926 Drug: Placebo Arm Phase 2

Detailed Description:
Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of IPI-926 in Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
Study Start Date : February 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: IPI-926
IPI-926
Drug: IPI-926
Oral

Placebo Comparator: Sugar Pill
Placebo Arm, sugar pill
Drug: Placebo Arm
oral placebo




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: estimated 6 months ]
    • To compare progression-free survival (PFS) in patients with metastatic or locally advanced (unresectable) chondrosarcoma administered IPI-926 or placebo.
    • Number of Incidence of reported adverse events and abnormal laboratory test results. To evaluate the safety of IPI-926 or placebo in patients with metastatic or locally advanced (unresectable) chondrosarcoma


Secondary Outcome Measures :
  1. Comparison of Time To Progression (TTP) [ Time Frame: estimated 6 months ]
    *To compare, Time To Progression (TTP) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo

  2. Comparison of Overall Survival (OS) [ Time Frame: estimated 6 months ]
    To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo

  3. Overall Response Rate (ORR) [ Time Frame: estimated 6 months ]
    To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age at the time of signing informed consent.
  • 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:

  • Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310816


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Locations
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United States, Arizona
(TGen) Translational Genomics Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, New South Wales
Sydney Cancer Centre
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Monash Medical Centre
East Bentleigh, Victoria, Australia, 3165
Austria
Medizinische Universität Wien
Wien, Vienna, Austria, 1090
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada
France
Institut de Cancérologie Gustave Roussy
Villejuif, Ile-de-france, France, 94805
Centre René Gauducheau
Saint Herblain cedex, Pays de La Loire, France, 44805
Centre Léon Bérard, Service d'Oncologie Médicale
Lyon, Rhone-alpes, France, 69373
Germany
Universitätsmedizin Mannheim
Mannheim, Baden-wuerttemberg, Germany, 68167
Helios Klinikum Bad Saarow
Bad Saarow, Brandenburg, Germany, 15526
Universitätsklinikum Essen
Essen, Nordrhein-westfalen, Germany, 45147
Italy
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
Netherlands
Leids Unversitair Medisch Centrum
Leiden, Zuid-Holland, Netherlands, 2333 ZA
Norway
Radiumhospitalet
Oslo, Norway, 0424
Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warszawa, Mazowieckie, Poland, 02-781
Russian Federation
SI Russian Oncological Research Center
Moscow, Russian Federation, 115478
Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies
Moscow, Russian Federation, 125284
Sweden
Skånes Universitetssjukhus
Lund, Skane, Sweden, 22185
United Kingdom
Royal Orthopaedic Hospital
Birmingham, England, United Kingdom, B312AP
University College Hospital
London, England, United Kingdom, NW1 2PQ
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE7 7DN
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
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Study Chair: Pedro Santabarbara, MD Infinity Pharmaceuticals, Inc.

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Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01310816     History of Changes
Other Study ID Numbers: IPI-926-04
First Posted: March 9, 2011    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013

Keywords provided by Infinity Pharmaceuticals, Inc.:
malignant neoplasms of the bone
bone sarcoma

Additional relevant MeSH terms:
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Chondrosarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma