Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.

Inclusion Criteria

• •1. Patients with solid tumors (except pancreatic cancer) or non-Hodgkin lymphoma
• •2. Metastatic disease or locally advanced inoperable tumor, not accessible to standard therapy.
• •3. Male or female ≥ 18 years and \<80 years.
• •4. Tumor assessable by RECIST v1.1, Scher Cheson 2008 or 99.
• •5. At least 28 days after completion of prior treatment (radiotherapy, systemic chemotherapy or major surgery).
• •6. Patient who recovered from any prior toxicity ≤ grade 1.
• •7. WHO 0-1 in the 7 days before inclusion.
• •8. Neutrophils ≥ 1500/mm3, Platelets ≥ 100 000/mm3.
• •9. Total bilirubin and serum creatinine within normal limits (≤ 1.5 ULN), creatinine clearance ≥ 40 ml / min.
• •10. AST / ALT ≤ 1.5 ULN (≤ 5 ULN if liver metastasis).
• •11. Normal thyroid function.
• •12. Normal coagulation: TP ≥ 70%.
• •13. Life expectancy upper than 3 months.
• •14. HAD score \<13.
• •15. Negative pregnancy test for women likely to be pregnant within 7 days before inclusion.
• •16. Effective contraception for the duration of treatment (for both sexes in childbearing or reproductive age): mechanic contraception method should always be used in combination with other contraceptive methods (eg, oral or other hormonal contraceptives). Because of long half-life of efavirenz, it is recommended to use adequate contraceptive measures for 12 weeks after stopping treatment with efavirenz.
• •17. Informed consent signed and dated by the patient or his legal representative before the establishment of any specific procedure to the study.
• •18. Clinical examination and laboratory tests made within 7 days before enrollment and start of treatment.
• •19. Initial assessment and radiological CT / or MRI performed within 30 days before enrollment.
• •20. Patients potentially compliant with treatment and follow-up study.
• •21. Ability to swallow capsules or tablets.
• •22. Patients insured by a social security system.