Pharmacokinetics and pharmacodynamics of 9-cis-retinoic acid in healthy men

Journal of Clinical Pharmacology

Volumn 37, Issue 7, 1997, Pages 566-574

  Weber, Cornelia ^a   Dumont, Etienne ^a  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ALITRETINOIN;

ARTICLE; CANCER; CANCER PREVENTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG ELIMINATION; DRUG SAFETY; DRUG TOLERANCE; HEADACHE; HUMAN; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; RANDOMIZED CONTROLLED TRIAL; XERODERMA PIGMENTOSUM;

EID: 0030800347     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1002/j.1552-4604.1997.tb04338.x     Document Type: Article

References (29)

1. Smith MA, Parkinson DR, Cheson BD, Friedman MA: Retinoids in cancer therapy. J Clin Oncol 1992;10:839-864.
2. Vahlquist A: Role of retinoids in normal and diseased skin. In, R. Blomhoff (ed.): Vitamin A in Health and Disease. New York: Marcel Dekker, 1994;365-424.
3. Bollag W: Prevention and therapy of precancerous and cancerous lesions by retinoids: experimental and clinical aspects. In, Marks PA, Türler H (eds.): Precancerous Lesions: A Multidisciplinary Approach. Rome: Ares-Serono Symposia, 1993;243-254.
4. Lippman SM, Kessler JF, Meyskens FL: Retinoids as preventive and anticancer agents (part II). Cancer Treat Rep 1987;71:493-515.
5. Levin AA, Sturzenbecker LJ, Kazmer S, Bosakowski T, Huselton C. Allenby G, et al: 9-cis retinoic acid stereoisomer binds and activates the nuclear receptor RXRα. Nature 1992;355:359-361.
6. Heyraan RA, Mangelsdorf DJ, Dyck JA, Stein RB, Eichele G, Evans RM, Thaller C: 9-cis-retinoic acid is a high affinity ligand for the retinoid X receptor. Cell 1992;68:397-406.
7. Mangelsdorf DJ, Borgmeyer U, Heyman RA, Zhon JY, Ong ES, Oro AE, et al: Characterisation of three RXR genes that mediate the action of 9-cis retinoic acid. Genes Dev 1992;6:329-344.
8. Allenby G, Bocquel M-T, Saunders M, Kazmer S, Speck J, Rosenberger M, et al: Retinoic acid receptors and retinoid X receptors: interactions with endogenous retinoic acids. Proc Natl Acad Sci U S A 1993;90:30-34.
9. Kizaki M, Ikeda Y, Tanosaki R, Nakajima H, Morikawa M, Sakashita A, Koeffler HP: Effects of novel retinoic acid compound, 9-cis-retinoic acid, on proliferation, differentiation, and expression of retinoic acid receptor-α and retinoic X receptor-α RNA by HL-60 cells. Blood 1993;82:3592-3599.
10. Matsushima Y, Kawachi E, Tanaka H, Kagechika H, Hashinototot Y, Shudo K, et al: Differentiation-inducing activity of retinoic acid isomers and their oxidized analogs on human promyelyctic leukemia HL-60 cells. Biochem Biophys Res Comm 1992; 189:1136-1142.
11. Sakashita A, Kizaki M, Pakkala S, Schiller G, Tsurnoka N, Tomosaki R, et al: 9-cis-retinoic acid: effects on normal and leukemic hematopoiesis in vitro. Blood 1993;81:1009-1016.
12. Marth C, Widschwendter M, Daxenbichler G: Mechanism of synergistic action of all-trans-or 9-cis-retinoic acid and interferons in breast cancer cells. J Steroid Biochem Molec Biol 1993;47:123-126.
13. Kurie JM, Lee JS, Griffin T, et al: Phase I trial of 9-cis-retinoic acid in adults with solid tumors. Clin Cancer Res 1996;2:287-293.
14. Rigas JR, Miller VA, Benedetti FM, Tong WP, Gill GM, Truglia JA, et al: Phase I clinical and pharmacologic study of 9-cis retinoic acid (LGD1057) (abstract). Proc Am Soc Clin Oncol 1995;14:171.
15. Benedetti F, Tong W, Gill G, Truglia J, Warrell RP: Initial clinical study of 9-cis retinoic acid (LGD1057) in acute promyelocytic leukemia (APL) (abstract). Proc Am Soc Oncol 1995;14:337.
16. Adamson PC, Boylan JF, Balis FM, Murphy RF, Godwin KA, Gudas LJ, Poplack DG: Time course of induction of metabolism of all-trans retinoic acid and the up-regulation of cellular retinoic acid binding protein. Cancer Res 1993;53:472-476.
17. Muindi J, Frankel SR, Miller WH, Jakubowski A, Scheinberg DA, Young CW, et al: Continuous treatment with all-frans retinoic acid causes a progressive reduction in plasma drug concentrations: implications for relapse and retinoid "resistance" in patients with acute promyelocytic leukemia. Blood 1992;79:299-303.
18. Smith MA, Admanson PC, Balis FM, Feusner J, Aronson L, Murphy RF, et al: Phase I and pharmacokinetic evaluation of all-trans retinoic acid in pediatric patients with cancer. J Clin Oncol 1992;10:1666-1673.
19. Sass JO, Masgrau E, Saurat J-H, Nan H: Metabolism of oral 9-cis-retinoic acid in the human: identification of 9-cis-retinoyl-β-glucuronide and 9-cis-4-oxo-retinoyl-β-glucuronide as urinary metabolites. Drug Met Dispos 1995;23:887-891.
20. Homan ER: Quantitative relationships between toxic doses of antitumor chemotherapeutic agents in animals and man. Cancer Chemother Rep 1972;3:13-19.
21. Penta JS, Rosner GL, Trump DL: Choice of starting dose and escalation for phase I studies of antitumour agents. Cancer Chemother Pharmacol 1992;31:247-250.
22. Vuilleumier JP, Keller HE, Gysel D, Hunziker F: Clinical chemical methods for the routine assessment of the vitamin status in human populations, I: the fat-soluble vitamins A and E and β carotene. Int J Vit Nutr Res 1983;53:265-272.
23. Gibaldi M, Perrier D: Pharmacokinetics. Second Edition. New York: Marcel Dekker, 1982.
24. Formelli F, Carsana R, Costa A, Buranelli F, Campa T, Dossena G, et al: Plasma retinol level reduction by the synthetic retinol fenretidine: a one year follow-up study of breast cancer patients. Cancer Res 1989;49:6149-6152.
25. Lucek RW, Colburn WA: Clinical pharmacokinetics of the retinoids. Clin Pharmacokinet 1985;10:38-62.
26. Allen JG, Bloxham DP: The pharmacology and pharmacokinetics of the retinoids. Pharmacol Ther 1989;40:1-27.
27. Berni R: Research communications. Retinoids: in vitro interaction with retinol binding protein and influence of plasma retinol. FASEB J 1993;7:1179-1184.
28. Dew SE: Effects of pharmacological retinoids on several vitamin A - metabolizing enzymes. Cancer Res 1993;53:2965-2969.
29. Formelli F, Clerici H, Campa T, Di Mauro MG, Magni A, Mascotti G, et al: Five-year administration of fenretidine: pharmacokinetics and effects on plasma retinol concentrations. J Clin Oncol 1993;11:2036-2042.