A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
Primary Purpose
Conventional Chondrosarcoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
IPI-926
Placebo Arm
Sponsored by
About this trial
This is an interventional treatment trial for Conventional Chondrosarcoma focused on measuring malignant neoplasms of the bone, bone sarcoma
Eligibility 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
Sites / Locations
- (TGen) Translational Genomics Research Institute
- Sarcoma Oncology Center
- University of Colorado Cancer Center
- University of Miami - Sylvester Comprehensive Cancer Center
- Dana-Farber Cancer Institute
- University of Michigan
- Mayo Clinic
- Washington University in St. Louis
- Columbia University Medical Center
- OHSU Knight Cancer Institute
- Pennsylvania Oncology Hematology Associates
- Fox Chase Cancer Center
- Medical University of South Carolina
- MD Anderson Cancer Center
- University of Washington - Seattle Cancer Care Alliance
- Sydney Cancer Centre
- Monash Medical Centre
- Medizinische Universität Wien
- Mount Sinai Hospital
- Institut de Cancérologie Gustave Roussy
- Centre René Gauducheau
- Centre Léon Bérard, Service d'Oncologie Médicale
- Universitätsmedizin Mannheim
- Helios Klinikum Bad Saarow
- Universitätsklinikum Essen
- IRCCS Istituto Ortopedico Rizzoli
- Fondazione IRCCS Istituto Nazionale dei Tumori
- Leids Unversitair Medisch Centrum
- Radiumhospitalet
- Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie
- SI Russian Oncological Research Center
- Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies
- Skånes Universitetssjukhus
- Royal Orthopaedic Hospital
- University College Hospital
- Newcastle General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IPI-926
Sugar Pill
Arm Description
IPI-926
Placebo Arm, sugar pill
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Comparison of Overall Survival (OS)
To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Overall Response Rate (ORR)
To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Full Information
NCT ID
NCT01310816
First Posted
March 3, 2011
Last Updated
December 4, 2013
Sponsor
Infinity Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01310816
Brief Title
A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
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 Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infinity Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in patients with Chondrosarcoma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conventional Chondrosarcoma
Keywords
malignant neoplasms of the bone, bone sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPI-926
Arm Type
Active Comparator
Arm Description
IPI-926
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Placebo Arm, sugar pill
Intervention Type
Drug
Intervention Name(s)
IPI-926
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo Arm
Intervention Description
oral placebo
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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
Time Frame
estimated 6 months
Secondary Outcome Measure Information:
Title
Comparison of Time To Progression (TTP)
Description
*To compare, Time To Progression (TTP) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Time Frame
estimated 6 months
Title
Comparison of Overall Survival (OS)
Description
To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Time Frame
estimated 6 months
Title
Overall Response Rate (ORR)
Description
To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Time Frame
estimated 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Santabarbara, MD
Organizational Affiliation
Infinity Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
(TGen) Translational Genomics Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Miami - Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Sydney Cancer Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Monash Medical Centre
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
Facility Name
Medizinische Universität Wien
City
Wien
State/Province
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Institut de Cancérologie Gustave Roussy
City
Villejuif
State/Province
Ile-de-france
ZIP/Postal Code
94805
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain cedex
State/Province
Pays de La Loire
ZIP/Postal Code
44805
Country
France
Facility Name
Centre Léon Bérard, Service d'Oncologie Médicale
City
Lyon
State/Province
Rhone-alpes
ZIP/Postal Code
69373
Country
France
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
State/Province
Baden-wuerttemberg
ZIP/Postal Code
68167
Country
Germany
Facility Name
Helios Klinikum Bad Saarow
City
Bad Saarow
State/Province
Brandenburg
ZIP/Postal Code
15526
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
State/Province
Nordrhein-westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
IRCCS Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Leids Unversitair Medisch Centrum
City
Leiden
State/Province
Zuid-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Radiumhospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie w Warszawie
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland
Facility Name
SI Russian Oncological Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow n.a. P.A Herzen Oncology Research Institute of Rosmedtechnologies
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Skånes Universitetssjukhus
City
Lund
State/Province
Skane
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Royal Orthopaedic Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B312AP
Country
United Kingdom
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
NW1 2PQ
Country
United Kingdom
Facility Name
Newcastle General Hospital
City
Newcastle Upon Tyne
State/Province
England
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
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