A study evaluating IPI-926 in patients with Chondrosarcoma

• Research type

  Research Study

• Full 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

• IRAS ID

  74609

• Contact name

  Jeremy Whelan

• Sponsor organisation

  Infinity Pharmaceuticals, Inc.

• Eudract number

  2010-024518-74

• ISRCTN Number

  Not given

• Research summary

  A phase 2, double-blind, placebo controlled study to evaluate the safety and effectiveness of IPI-926 in patients with metastatic or locally advanced chondrosarcomaThis study is being conducted to evaluate how safe and effective IPI-926 is in patients with metastatic or locally advanced chondrosarcoma (the cancer has spread from the bones to other parts of the body or has spread to an extent that cannot be removed completely through surgery). Chondrosarcoma begins in the cartilage cells before spreading to the bone. Normal cells in the body'se pathways during development that are then turned off in adulthood. One such pathway is known as the ??hedgehog pathway.? Recent scientific research has shown that cancer cells turn this pathway back on, and that blocking this pathway may cause cancer cells to die. IPI-926 is a medication which is designed to block this pathway. About 108 subjects will take part in this study at various study sites worldwide. In the UK, the study will be performed by suitably qualified oncologists at NHS hospitals. The maximum number of months of study treatment is expected to be 24. When a participant discontinues or completes the study, the clinical research site will contact him/her approximately every 3 months for up to 2 years and once again at year 3 to collect survival data. The duration of study participation is expected to be approximately 5 years which includes follow-up.The participants will be randomly assigned to receive IPI-926 or placebo and they will have 2 in 3 chances to receive IPI-926. This study also includes an optional open-label portion only for participants who received placebo. That means any participants who received placebo in the blinded portion of the study, can receive IPI-926 once their disease progresses. The participants will have to undergo physical examinations, ECGs, blood tests, tumour biopsies and complete diaries and a questionnaire.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/0351

• Date of REC Opinion

  14 Jun 2011

• REC opinion

  Further Information Favourable Opinion