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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.

Tracking Information
First Submitted Date  ICMJE March 3, 2011
First Posted Date  ICMJE March 9, 2011
Last Update Posted Date December 5, 2013
Study Start Date  ICMJE February 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2011)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Conventional Chondrosarcoma
Intervention  ICMJE
  • Drug: IPI-926
    Oral
  • Drug: Placebo Arm
    oral placebo
Study Arms  ICMJE
  • Active Comparator: IPI-926
    IPI-926
    Intervention: Drug: IPI-926
  • Placebo Comparator: Sugar Pill
    Placebo Arm, sugar pill
    Intervention: Drug: Placebo Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2012)
105
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2011)
108
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   France,   Germany,   Italy,   Netherlands,   Norway,   Poland,   Russian Federation,   Sweden,   United Kingdom,   United States
Removed Location Countries Romania
 
Administrative Information
NCT Number  ICMJE NCT01310816
Other Study ID Numbers  ICMJE IPI-926-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Infinity Pharmaceuticals, Inc.
Study Sponsor  ICMJE Infinity Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Pedro Santabarbara, MD Infinity Pharmaceuticals, Inc.
PRS Account Infinity Pharmaceuticals, Inc.
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP