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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

Phase 2
18 Years
Open (Enrolling)
Conventional Chondrosarcoma

Thank you

Trial Information

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 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.

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

- 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

- Presence of active infection or systemic use of antibiotics within 72 hours of

- 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

- Known human immunodeficiency virus (HIV) positivity.

- Known hypersensitivity to IPI-926, or any of the excipients in IPI-926 or placebo

- Pregnant or lactating women.

- Current administration of the medications or foods which are known to be moderate or
strong inhibitors of CYP3A4 activity

Type of Study:


Study Design:

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

Outcome Measure:

Progression Free Survival (PFS)

Outcome 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

Outcome Time Frame:

estimated 6 months

Safety Issue:


Principal Investigator

Pedro Santabarbara, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Infinity Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

September 2013

Related Keywords:

  • Conventional Chondrosarcoma
  • malignant neoplasms of the bone
  • bone sarcoma
  • Chondrosarcoma



University of MichiganAnn Arbor, Michigan  48109-0624
MD Anderson Cancer CenterHouston, Texas  77030-4096
Mayo ClinicRochester, Minnesota  55905
University of Colorado Cancer CenterDenver, Colorado  80262
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
OHSU Knight Cancer InstitutePortland, Oregon  97239
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
Columbia University Medical CenterNew York, New York  10032
Sarcoma Oncology CenterSanta Monica, California  90403
Washington University in St. LouisSt. Louis, Missouri  63110
University of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida  33136
(TGen) Translational Genomics Research InstituteScottsdale, Arizona  85258
University of Washington - Seattle Cancer Care AllianceSeattle, Washington  98109