Etude de phase 1 évaluant le RAD001 en association avec la radiothérapie dans les cancers bronchiques non à petites cellules

Withdrawn

• Conditions: lung cancer; 10029107

• Registration Number: NL-OMON33139
• Lead Sponsor: ederlands Kanker Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1) Unresectable non-small cell lung cancer, stage IIIA/B, or stage IV for which the primary tumor is symptomatic (cough, dyspnea, pain) without extra-thoracic lesions rapidly evolving
2) Measurable lesion, documented histologically, potentially accessible during fiberoptic bronchoscopy.
3) Age > 18 years, WHO 0-1,
4) Neutrophil count > 1500 /mm3, Hemoglobin > 9 g/dL, Platelet count > 100,000/mm3
5) Bilirubin < 1.5 mg/dL, Transaminases < 3 N, albumin >30 g / L, PT > 70%
6) Creatinine < 120 µM/L
7) Patient information and informed consent form signed.
8) No previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).

Exclusion Criteria

1) Patients previously treated with RAD001 (everolimus) or any other mTOR inhibitor
2) Stage IV for which the primary tumor is not symptomatic with extra-thoracic lesions rapidly evolving requiring systemic treatment
3) Previous radiotherapy,
4) Venous or arterial thrombosis, pulmonary embolism during the previous six months
5) Concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent, history of epilepsy
6) Concomitant treatment with medicinal products that inhibit, induce or are substrates for CYP3A4

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: to evaluate the tolerability of the combination of RAD001<br /><br>with radiotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective(s) To determine the antitumor activity of the combination<br /><br>of RAD001 (EVEROLIMUS) and radiotherapy (CR+PR+SD). To determine the<br /><br>progression-free survival and the overall survival.</p><br>