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

NCT01412515 | Terminated Phase 2

• 1 other identifier: C06-46
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Kaposi Sarcoma

Keywords

mTOR inhibitors

Outcome Measures

Primary Outcomes (1)

• objective response to everolimus after 6 months therapy

  objective response to everolimus after 6 months therapy (complete or partial response per ACTG criteria).

  duration of study 30 months

Secondary Outcomes (1)

• response according to physician global assessment, lesions size , lesions infiltration

  30 months

Study Arms (1)

Everolimus

EXPERIMENTAL

everolimus 10 mg per day

Drug: everolimus

Interventions

everolimus DRUG

everolimus per os 10mg per day

Everolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• immunosupressive regimen patients HIV positive creatinine clearance \<40ml/mn,AST ALT\>3N, neutropénia\<1500, thrombopenia\<150000, anemia\<8g/dL

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Hospital Saint Louis

Paris, 75010, France

Location

MeSH Terms

Conditions

Sarcoma, Kaposi

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Officials

• Celeste Lebbé, MD, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 9, 2011
• Study Start: June 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 2, 2012

Record last verified: 2011-08

Locations

FR (1)