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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01310816




Registration number
NCT01310816
Ethics application status
Date submitted
3/03/2011
Date registered
9/03/2011
Date last updated
5/12/2013

Titles & IDs
Public title
A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
Scientific 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
Secondary ID [1] 0 0
IPI-926-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Conventional Chondrosarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IPI-926
Treatment: Drugs - Placebo Arm

Active Comparator: IPI-926 - IPI-926

Placebo Comparator: Sugar Pill - Placebo Arm, sugar pill


Treatment: Drugs: IPI-926
Oral

Treatment: Drugs: Placebo Arm
oral placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
estimated 6 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
estimated 6 months
Secondary outcome [2] 0 0
Comparison of Overall Survival (OS) - To compare Overall Survival (OS) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Timepoint [2] 0 0
estimated 6 months
Secondary outcome [3] 0 0
Overall Response Rate (ORR) - To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo
Timepoint [3] 0 0
estimated 6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Cancer Centre - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre - East Bentleigh
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3165 - East Bentleigh
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Oregon
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Austria
State/province [15] 0 0
Vienna
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
France
State/province [17] 0 0
Ile-de-france
Country [18] 0 0
France
State/province [18] 0 0
Pays de La Loire
Country [19] 0 0
France
State/province [19] 0 0
Rhone-alpes
Country [20] 0 0
Germany
State/province [20] 0 0
Baden-wuerttemberg
Country [21] 0 0
Germany
State/province [21] 0 0
Brandenburg
Country [22] 0 0
Germany
State/province [22] 0 0
Nordrhein-westfalen
Country [23] 0 0
Italy
State/province [23] 0 0
Bologna
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Netherlands
State/province [25] 0 0
Zuid-Holland
Country [26] 0 0
Norway
State/province [26] 0 0
Oslo
Country [27] 0 0
Poland
State/province [27] 0 0
Mazowieckie
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Moscow
Country [29] 0 0
Sweden
State/province [29] 0 0
Skane
Country [30] 0 0
United Kingdom
State/province [30] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Infinity Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
IPI-926 is an inhibitor of the hedgehog pathway. IPI-926 may improve therapeutic outcomes in
patients with Chondrosarcoma.
Trial website
https://clinicaltrials.gov/show/NCT01310816
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pedro Santabarbara, MD
Address 0 0
Infinity Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications