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

Phase 1
18 Years
80 Years
Open (Enrolling)
Solid Tumors, Non-Hodgkin's Lymphoma

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Trial Information

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

Inclusion Criteria

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

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

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

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.

Exclusion Criteria :

1. Patient with pancreatic cancer.

2. Presence of active or symptomatic cerebral localization (known).

3. History of another cancer except:

- cancer occurred more than five years and considered in complete remission

- in situ cervix carcinomas,

- cutaneous basal cell carcinomas.

4. Current major depressive state (screening by HAD scale total score ≥ 13).

5. Patients with history of depressive disorders, suicide attempts, addiction or other
psychiatric disorders.

6. Concomitant use of terfenadine, astemizole, cisapride, midazolam, triazolam,
pimozide, bepridil, alkaloids of ergot, voriconazole, mixing St. John's Wort.

7. Patients treated with anti-vitamin K. Treatment with low molecular weight heparin are

8. Known efavirenz hypersensitivity or to any of its excipients.

9. Severe renal impairment.

10. Severe hepatic impairment.

11. Yellow fever vaccine (yellow fever).

12. Pregnant or lactating.

13. Presence of toxicity> 1 according to the criteria CTCAE V4.0, due to prior cancer

14. Recurrent diarrhea which can interfere with drug absorption capacity.

15. Patient included in another biomedical research on a drug within 30 days of

16. Patient who previously participated in this study.

17. 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tolerability will be evaluated according to the classification of the toxicity scale NCI-CTCAE v4.0

Outcome 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: Any drug-related toxicity with grade ≥ 3 according to NCI-CTCAE v4.0 (except alopecia, nausea and vomiting, regardless of grade), Any drug-related toxicity, regardless of grade, who led a treatment delay> 14 days, Score ≥ 19 HAD during treatment.

Outcome Time Frame:

Dose limiting toxicities will be collected during the first 28 days (+ / - 7 days) after first dose of Efavirenz.

Safety Issue:


Principal Investigator

Nadine Houédé, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2011

Completion Date:

December 2015

Related Keywords:

  • Solid Tumors
  • Non-Hodgkin's Lymphoma
  • Solid tumors (other than pancreas)
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Neoplasms