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

Conventional Chondrosarcoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310816
• Other study ID #: IPI-926-04
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2011
• Last updated: December 4, 2013
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Infinity Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chondrosarcoma
• Conventional Chondrosarcoma

Intervention

Drug:
• IPI-926
Oral
• Placebo Arm
oral placebo

Locations

Country	Name	City	State
Australia	Sydney Cancer Centre	Camperdown	New South Wales
Australia	Monash Medical Centre	East Bentleigh	Victoria
Austria	Medizinische Universität Wien	Wien	Vienna
Canada	Mount Sinai Hospital	Toronto	Ontario
France	Centre Léon Bérard, Service d'Oncologie Médicale	Lyon	Rhone-alpes
France	Centre René Gauducheau	Saint Herblain cedex	Pays de La Loire
France	Institut de Cancérologie Gustave Roussy	Villejuif	Ile-de-france
Germany	Helios Klinikum Bad Saarow	Bad Saarow	Brandenburg
Germany	Universitätsklinikum Essen	Essen	Nordrhein-westfalen
Germany	Universitätsmedizin Mannheim	Mannheim	Baden-wuerttemberg
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Netherlands	Leids Unversitair Medisch Centrum	Leiden	Zuid-Holland
Norway	Radiumhospitalet	Oslo
Poland	Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie	Warszawa	Mazowieckie
Russian Federation	Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies	Moscow
Russian Federation	SI Russian Oncological Research Center	Moscow
Sweden	Skånes Universitetssjukhus	Lund	Skane
United Kingdom	Royal Orthopaedic Hospital	Birmingham	England
United Kingdom	University College Hospital	London	England
United Kingdom	Newcastle General Hospital	Newcastle Upon Tyne	England
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Columbia University Medical Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania
United States	OHSU Knight Cancer Institute	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Sarcoma Oncology Center	Santa Monica	California
United States	(TGen) Translational Genomics Research Institute	Scottsdale	Arizona
United States	University of Washington - Seattle Cancer Care Alliance	Seattle	Washington
United States	Washington University in St. Louis	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Infinity Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy,  Netherlands,  Norway,  Poland,  Russian Federation,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Comparison of Time To Progression (TTP)	*To compare, Time To Progression (TTP) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo	estimated 6 months	No
Secondary	Comparison of Overall Survival (OS)	To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo	estimated 6 months	No
Secondary	Overall Response Rate (ORR)	To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo	estimated 6 months	No