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Hypothesis: encouraging results of phase II study FAVE in the treatment of hormonal resistant prostate cancer lead us to continue clinical development of efavirenz. Furthermore, all available pre-clinical and clinical data lead us to conduct a Phase 1 study with efavirenz. Objective of this Phase I is to test doses above 600 mg / day in patients with cancer in order to determine the maximum tolerated dose to improve therapeutic effect.
This study is a single center Phase I trial, conduct with dose escalation scheme of efavirenz by continual reassessment method likehood approach (CRML) on solid tumours (except pancreatic cancer) and non-Hodgkin lymphoma (NHL).
Main objective is to determine the safety profile, and particularly the maximum tolerated dose of efavirenz for the treatment of patients with solid tumors (except pancreatic cancer) or NHL in therapeutic failure.
Secondary objectives are:
Primary Endpoint
Safety will be evaluated according to the toxicity scale NCI-CTCAE v4.0. Dose limiting toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of Efavirenz and will be defined as follows:
Full description
This is a Phase I dose escalation strategy according to the method described by CRML O'Quigley and Shen [O'Quigley et al. Biometrics 1996] and commonly used in phase I trials in oncology.
Six levels of doses are initially defined: 600 mg, 1200 mg, 1800 mg, 2200 mg, 2600 mg, 3000 mg.
The maximum potential dose-limiting toxicities allowed is 25%.
Dose limiting toxicities will be defined as follows:
Enrollment
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Volunteers
Inclusion and exclusion criteria
Inclusion Criteria :
Exclusion Criteria :
Patient with pancreatic cancer.
Presence of active or symptomatic cerebral localization (known).
History of another cancer except:
Current major depressive state (screening by HAD scale total score ≥ 13).
Patients with history of depressive disorders, suicide attempts, addiction or other psychiatric disorders.
Concomitant use of terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, alkaloids of ergot, voriconazole, mixing St. John's Wort.
Patients treated with anti-vitamin K. Treatment with low molecular weight heparin are allowed.
Known efavirenz hypersensitivity or to any of its excipients.
Severe renal impairment.
Severe hepatic impairment.
Yellow fever vaccine (yellow fever).
Pregnant or lactating.
Presence of toxicity> 1 according to the criteria CTCAE V4.0, due to prior cancer therapy.
Recurrent diarrhea which can interfere with drug absorption capacity.
Patient included in another biomedical research on a drug within 30 days of inclusion.
Patient who previously participated in this study.
Patient, who for reasons psychological, psychiatric, social, family or geographical could not be treated or monitored regularly by the criteria of the study, patients deprived of liberty or under tutorship.
Primary purpose
Allocation
Interventional model
Masking
25 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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