A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma
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| First Received Date ICMJE | August 8, 2011 | ||||
| Last Updated Date | December 29, 2011 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
objective response to everolimus after 6 months therapy [ Time Frame: duration of study 30 months ] [ Designated as safety issue: No ] objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01412515 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
response according to physician global assessment, lesions size , lesions infiltration [ Time Frame: 30 months ] [ Designated as safety issue: No ] response according to physician global assessment, lesions size , lesions infiltration |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma | ||||
| Official Title ICMJE | A Phase II Study With Tumor Molecular Pharmacodynamic (MPD) Evaluation of Oral mTOR-inhibitor Everolimus (RAD001) 10 mg Daily in Patients Suffering From Classic or Endemic Kaposi's Sarcoma | ||||
| Brief Summary | Classic Kaposi's sarcoma (CKS) is an angioproliferation associated with human herpes virus 8 (HHV8), which sometimes requires systemic treatment. Rapamycin and everolimus are mTOR inhibitors. The PI3K-AKT-mTOR pathway is activated in CKS.The aim of this study is to evaluate the rate of clinical response and tolerance to everolimus 10mg/d in CKS. Patients suffering from CKS will be enrolled in a multicenter two-stage phase II trial. At inclusion, all patients will have at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral CKS. The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). The trial is planned using Simon's minimax two-stage design to demonstrate a response rate of 50% as compared to 20% with type I error rate 2.5% and power of 90%. Accordingly, 11 patients will to be enrolled in the first stage and provided at least 3 patients responded, 15 patients will be accrued in a second stage. |
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| Detailed Description | The primary endpoint is objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria). Secondary endpoints are response according to physician global assessment, lesions size , lesions infiltration, lymphedema, tolerance, pharmacodynamic (pathologic, angiogenic and lymphangiogenic biomarkers, HHV8 viral load sequential evaluation in the lesions, pharmacokinetic evaluation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Kaposi Sarcoma | ||||
| Intervention ICMJE | Drug: everolimus
everolimus per os 10mg per day |
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| Study Arm (s) | Experimental: Everolimus
everolimus 10 mg per day
Intervention: Drug: everolimus |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 11 | ||||
| Completion Date | May 2011 | ||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Histologic confirmed classic or endemic KS (non transplant non HIV patients) > 18 Years old at least 10 lesions or more than one limb or 3% of body surface affected, in the absence of symptomatic visceral KS Presence of at least 4 targets lesions > 5mm At least 4 weeks wash out from any KS specific therapy ECOG < 2 Exclusion Criteria: immunosupressive regimen patients HIV positive creatinine clearance <40ml/mn,AST ALT>3N, neutropénia<1500, thrombopenia<150000, anemia<8g/dL |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01412515 | ||||
| Other Study ID Numbers ICMJE | C06-46 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Study Sponsor ICMJE | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Institut National de la Santé Et de la Recherche Médicale, France | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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