A Pivotal Trial to Determine the Efficacy and Safety of AP23573 when Administered as Maintenance Therapy to Patients with Metastatic Soft Tissue or Bone Sarcomas.
A Phase 3, Randomised, Multi-Centre, Double Blinded, Placebo Controlled Trial to Determine the Efficacy and Safety of Oral AP23573 Versus Oral Placebo in Patients with Metastatic Sarcoma when Administered as Maintenance Therapy.
ARIAD Pharmaceuticals, Inc.
650 participants
Sep 1, 2007
Interventional
Conditions
Summary
Phase 3 This is a pivotal study to determine the effectiveness and safety of AP23573 (deforolimus) when administered as maintenance therapy to people with metastatic cancers of either soft tissue or bone. Who is it for? This trial is for you is you have metastatic cancers of either soft tissue or bone connective tissue, and have already had your cancer controlled by chemotherapy. Trial Details Participants will be randomly divided into two groups. One group will receive maintenance treatment with oral AP23573 (deforolimus) and the other will receive standard treatment. The trial aims to see whether those people receiving oral AP23573 (deforolimus) have better disease control compared to those receiving standard treatment. Deforolimus has shown promising activity in early phase trials and its side effects are generally mild and reversible and include mouth sores, fatigue and nausea.’ Deforolimus inhibits the protein mTOR, which is a ‘master switch’ in cancer cells. Blocking mTOR effectively ‘starves’ cancer cells by interfering with cell growth, division, metabolism, and blood vessel growth. If you have metastatic cancers of either soft tissue or bone connective tissue, you usually receive chemotherapy until the disease is controlled or until chemotherapy causes significant side effects. Chemotherapy is then stopped and your cancer specialist observes you regularly. This trial is testing whether, once the disease has been controlled with chemotherapy, treatment with oral AP23573 (deforolimus) can control the cancer for longer compared to standard treatment.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
This is a multi-centre, randomised Phase 3, double-blinded, placebo-controlled trial to determine the efficacy and safety of oral AP23573 (MK-8669) versus oral placebo in patients with metastatic sarcoma. Eligible patients include those with metastatic soft-tissue or bone sarcoma who have achieved a complete response, partial response or stable disease following 1st, 2nd or 3rd line chemotherapy for metastatic sarcoma. The trial is designed to test the hypothesis that a clinically significant improvement in progression-free survival will be induced in patients treated with AP23573 compared to placebo. It is anticipated that approximately 650 patients, age from 13 years will participate in this trial. AP23573 will be administered once daily as oral tablets for 5 consecutive days followed by a 2-day dosing holiday each week at a dose of 40 mg per day. Patients randomised to the placebo arm will receive matched tablets consisting of excipients without active drug Patients must have achieved an ongoing complete response, partial response or stable disease following prior therapy as defined by Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. The disease status at study entry will be confirmed through an independent radiographic review during the screening period (prior to randomisation). Only eligible patients will be randomized. Patients will be randomly assigned (1:1) to receive either AP23573 or placebo by oral administration. Treatment will continue until progressive disease by RECIST guidelines is documented or other discontinuation criteria are met. Patients will be stratified by geographical region, histological category (soft-tissue or bone sarcoma), and prior treatment (1st line or 2nd/3rd line). Disease assessments will be performed every 8 weeks and assessed in accordance with the RECIST guidelines. Patients will be followed for overall survival for at least 24 months and up to 60 months following randomisation.
Locations(26)
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ACTRN12608000214336