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

• ClinicalTrials.gov Identifier: NCT01310816
• Recruitment Status: Completed
• First Posted: March 9, 2011
• Last Update Posted: December 5, 2013
• Sponsor: Infinity Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Infinity Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: March 3, 2011
• First Posted Date: March 9, 2011
• Last Update Posted Date: December 5, 2013
• Study Start Date: February 2011
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Conventional Chondrosarcoma

Intervention

• Drug: IPI-926
  Oral
• Drug: Placebo Arm
  oral placebo

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 7, 2012): 105
• Original Estimated Enrollment (submitted: March 8, 2011): 108
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Canada, France, Germany, Italy, Netherlands, Norway, Poland, Russian Federation, Sweden, United Kingdom, United States
• Removed Location Countries: Romania

Administrative Information

• NCT Number: NCT01310816
• Other Study ID Numbers: IPI-926-04
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Infinity Pharmaceuticals, Inc.
• Study Sponsor: Infinity Pharmaceuticals, Inc.
• Collaborators: Not Provided

Investigators

• Study Chair: Pedro Santabarbara, MD; Infinity Pharmaceuticals, Inc.

• PRS Account: Infinity Pharmaceuticals, Inc.
• Verification Date: December 2013