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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01310816
First received: March 3, 2011
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Conventional Chondrosarcoma
Drug: IPI-926
Drug: Placebo Arm
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: estimated 6 months ] [ Designated as safety issue: Yes ]
    • 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) [ Time Frame: estimated 6 months ] [ Designated as safety issue: No ]
    *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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    To compare Overall Response Rate (ORR) with metastatic or locally advanced (unresectable) chondrosarcoma patients administered IPI-926 or placebo


Enrollment: 105
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IPI-926
IPI-926
Drug: IPI-926
Oral
Placebo Comparator: Sugar Pill
Placebo Arm, sugar pill
Drug: Placebo Arm
oral placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01310816

  Show 36 Study Locations
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Study Chair: Pedro Santabarbara, MD Infinity Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01310816     History of Changes
Other Study ID Numbers: IPI-926-04
Study First Received: March 3, 2011
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
malignant neoplasms of the bone
bone sarcoma

Additional relevant MeSH terms:
Chondrosarcoma
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on April 15, 2014