Clinical Trial: Efficacy and Safety of Imatinib in Chordoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Imatinib Mesylate in Chordoma
Brief Summary: Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in patients affected by chordoma, need to be confirmed by a Phase II study, whose primary endpoint will be the formal assessment of clinical and pathological response. Aim of the study will be to explore treatment's activity, but also the potential impact of tumor response, the feasibility and outcome of subsequent surgery and radiotherapy. In addition, patterns of tumour response need to be investigated as well, given the peculiar patterns of response shown with molecular-targeted therapy in solid tumors.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Tumor response [ Time Frame: Every 3 months for 2 years ]
Original Primary Outcome: Primary: Overall response rate; patterns of tumor response
Current Secondary Outcome:
- Overall survival [ Time Frame: 2 years ]from the first day of sudy treatment to the day of death for any cause
- Progression free survival [ Time Frame: 2 years ]from the first day of sudy treatment to the day of death for any cause or documented progression
- Safety and tolerability [ Time Frame: 2 years ]frequency of adverse events, abnormal lab values, bone pain, use of analgesic medication
- proportion of patients undergoing complete surgery [ Time Frame: 2 years ]number of pts undergoing complete surgery vs the one of pts not amenable to complete surgery at enrolment
Original Secondary Outcome: Secondary: Conversion rate to surgical resectability or non-demolitive surgical respectability; overall survival (OS), Progression-free survival (PFS).
Information By: Novartis
Dates:
Date Received: September 7, 2005
Date Started: October 2004
Date Completion:
Last Updated: February 21, 2017
Last Verified: February 2017