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

NCT01310816 | Completed Phase 2 DMC

• 1 other identifier: IPI-926-04
• Study Type: interventional
• Target: 105
• Locations: 12 countries
• Sites: 34

Brief Summary

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

Conditions

Conventional Chondrosarcoma

Keywords

malignant neoplasms of the bone; bone sarcoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  * 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

  estimated 6 months

Secondary Outcomes (3)

• Comparison of Time To Progression (TTP)

  estimated 6 months

• Comparison of Overall Survival (OS)

  estimated 6 months

• Overall Response Rate (ORR)

  estimated 6 months

Study Arms (2)

IPI-926

ACTIVE COMPARATOR

IPI-926

Drug: IPI-926

Sugar Pill

PLACEBO COMPARATOR

Placebo Arm, sugar pill

Drug: Placebo Arm

Interventions

IPI-926 DRUG

Oral

IPI-926

Placebo Arm DRUG

oral placebo

Sugar Pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Infinity Pharmaceuticals, Inc.: lead

Study Sites (36)

(TGen) Translational Genomics Research Institute

Scottsdale, Arizona, 85258, United States

Location

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

University of Miami - Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Sydney Cancer Centre

Camperdown, New South Wales, 2050, Australia

Location

Monash Medical Centre

East Bentleigh, Victoria, 3165, Australia

Location

Medizinische Universität Wien

Vienna, Vienna, 1090, Austria

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Centre Léon Bérard, Service d'Oncologie Médicale

Lyon, Auvergne-Rhône-Alpes, 69373, France

Location

Centre René Gauducheau

Saint-Herblain, Pays de la Loire Region, 44805, France

Location

Institut de Cancérologie Gustave Roussy

Villejuif, Île-de-France Region, 94805, France

Location

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Helios Klinikum Bad Saarow

Bad Saarow, Brandenburg, 15526, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

IRCCS Istituto Ortopedico Rizzoli

Bologna, Bologna, 40136, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milano, 20133, Italy

Location

Leids Unversitair Medisch Centrum

Leiden, South Holland, 2333 ZA, Netherlands

Location

Radiumhospitalet

Oslo, 0424, Norway

Location

Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

SI Russian Oncological Research Center

Moscow, Moscow, 115478, Russia

Location

Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies

Moscow, Moscow, 125284, Russia

Location

Skånes Universitetssjukhus

Lund, Skåne County, 22185, Sweden

Location

Royal Orthopaedic Hospital

Birmingham, England, B312AP, United Kingdom

Location

University College Hospital

London, England, NW1 2PQ, United Kingdom

Location

Newcastle General Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

IPI-926

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Pedro Santabarbara, MD

  Infinity Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 9, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

US (15); GB (3); FR (3); NO (1); IT (2); AU (1); DE (3); PL (1); RU (2); CA (1); NL (1); SE (1)