Evaluation of the pharmacodynamics and pharmacokinetics of the PARP inhibitor olaparib: A Phase i multicentre trial in patients scheduled for elective breast cancer surgery

Investigational New Drugs

Volumn 31, Issue 4, 2013, Pages 949-958

  Bundred, Nigel ^a   Gardovskis, Janis ^b   Jaskiewicz, Janusz ^c   Eglitis, Janis ^d   Paramonov, Viktor ^e   McCormack, Peter ^f   Swaisland, Helen ^f   Cavallin, Maria ^f   Parry, Tony ^f   Carmichael, James ^f,h   Dixon, J Michael ^g  

^a MANCHESTER UNIVERSITY NHS FOUNDATION TRUST   (United Kingdom)

^b RIGA STRADINS UNIVERSITY   (Latvia)

^c MEDICAL UNIVERSITY OF GDANSK   (Poland)

^d UNIVERSITY OF LATVIA   (Latvia)

^e Cherkassy Regional Hospital   (Ukraine)

^f ASTRAZENECA   (United Kingdom)

^g WESTERN GENERAL HOSPITAL   (United Kingdom)

^h Celgene   (Spain)

Author keywords

Breast cancer; Olaparib; Pharmacodynamics; Pharmacokinetics; Phase I

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; OLAPARIB; PROGESTERONE RECEPTOR;

ADULT; ANEMIA; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BIOLOGICAL MODEL; BREAST CANCER; BREAST SURGERY; CANCER INHIBITION; CANCER SURGERY; CONCENTRATION RESPONSE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DEEP VEIN THROMBOSIS; DIZZINESS; DOSE RESPONSE; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; DRUG TUMOR LEVEL; ELECTIVE SURGERY; EVENING DOSAGE; FEMALE; GLOMERULUS FILTRATION RATE; GLUCOSE BLOOD LEVEL; HUMAN; HUMAN CELL; HUMAN TISSUE; LIMIT OF QUANTITATION; LYMPHEDEMA; MAJOR CLINICAL STUDY; MALAISE; MAXIMUM PLASMA CONCENTRATION; MEDICATION COMPLIANCE; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; PATIENT COMPLIANCE; PERIPHERAL BLOOD MONONUCLEAR CELL; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; POSTOPERATIVE HEMORRHAGE; POSTOPERATIVE PAIN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; VOMITING; WOUND HEMORRHAGE;

BREAST NEOPLASMS; DEMOGRAPHY; ENZYME INHIBITORS; FEMALE; HUMANS; MIDDLE AGED; PHTHALAZINES; PIPERAZINES; POLY(ADP-RIBOSE) POLYMERASES; SURGICAL PROCEDURES, ELECTIVE;

EID: 84880918621     PISSN: 01676997     EISSN: 15730646     Source Type: Journal    
DOI: 10.1007/s10637-012-9922-7     Document Type: Article

References (21)

1. Rouleau M, Patel A, Hendzel MJ, Kaufmann SH, Poirier GG (2010) PARP inhibition: PARP1 and beyond. Nat Rev Cancer 10:293-301
2. Baute J, Depicker A (2008) Base excision repair and its role in maintaining genome stability. Crit Rev Biochem Mol Biol 43:239-276
3. Gudmundsdottir K, Ashworth A (2006) The roles of BRCA1 and BRCA2 and associated proteins in the maintenance of genomic stability. Oncogene 25:5864-5874
4. McCabe N, Turner NC, Lord CJ, Kluzek K, Bialkowska A, Swift S, Giavara S, O'Connor MJ, Tutt AN, Zdzienicka MZ, Smith GCM, Ashworth A (2006) Deficiency in the repair of DNA damage by homologous recombination and sensitivity to Poly(ADP-Ribose) polymerase inhibition. Cancer Res 66:8109-8115
5. Ashworth A (2008) A synthetic lethal therapeutic approach: poly(ADP) ribose polymerase inhibitors for the treatment of cancers deficient in DNA double-strand break repair. J Clin Oncol 26:3785-3790
6. Nijman SM (2011) Synthetic lethality: general principles, utility and detection using genetic screens in human cells. FEBS Lett 585:1-6
7. Evers B, Drost R, Schut E, de Bruin M, van der Burg E, Derksen PW, Holstege H, Liu X, van Drunen E, Beverloo HB, Smith GC, Martin NM, Lau A, O'Connor MJ, Jonkers J (2008) Selective inhibition of BRCA2-deficient mammary tumor cell growth by AZD2281 and cisplatin. Clin Cancer Res 14:3916-3925
8. Menear KA, Adcock C, Boulter R, Cockcroft XL, Copsey L, Cranston A, Dillon KJ, Drzewiecki J, Garman S, Gomez S, Javaid H, Kerrigan F, Knights C, Lau A, Loh VM Jr, Matthews IT, Moore S, O'Connor MJ, Smith GC, Martin NM (2008) 4-[3-(4-cyclopropanecarbonylpiperazine-1-carbonyl)-4-fluorobenzyl]-2H-phth alazin-1-one: a novel bioavailable inhibitor of poly(ADP-ribose) polymerase-1. J Med Chem 51:6581-6591
9. Rottenberg S, Jaspers JE, Kersbergen A, van der Burg E, Nygren AO, Zander SA, Derksen PW, de Bruin M, Zevenhoven J, Lau A, Boulter R, Cranston A, O'Connor MJ, Martin NM, Borst P, Jonkers J (2008) High sensitivity of BRCA1-deficient mammary tumors to the PARP inhibitor AZD2281 alone and in combination with platinum drugs. Proc Natl Acad Sci USA 105:17079-17084
10. Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JHM, de Bono JS (2009) Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med 361:123-134
11. AstraZeneca. Global Policy: Bioethics. 2011. Available at: http://www.astrazeneca.com/Responsibility/Code-policies-standards/ Policiesstandards
12. Yamamoto N, Nokihara H, Yamada Y, Goto Y, Tanioka M, Shibata T, Yamada K, Asahina H, Kawata T, Shi X, Tamura T (2012) A Phase I, dose-finding and pharmacokinetic study of olaparib (AZD2281) in Japanese patients with advanced solid tumors. Canc Sci 103(3):504-509
13. Zaremba T, Thomas HD, Cole M, Coulthard SA, Plummer ER, Curtin NJ (2011) Poly(ADP-ribose) polymerase-1 (PARP-1) pharmacogenetics, activity and expression analysis in cancer patients and healthy volunteers. Biochem J 436:671-679
14. Ranjit GB, Cheng MF, Mackay W, Whitacre CM, Berger JS, Berger NA (1995) Poly(adenosine diphosphoribose) polymerase in peripheral blood leukocytes from normal donors and patients with malignancies. Clin Cancer Res 1:223-234
15. Plummer ER, Middleton MR, Jones C, Olsen A, Hickson I, McHugh P, Margison GP, McGown G, Thorncroft M, Watson AJ, Boddy AV, Calvert AH, Harris AL, Newell DR, Curtin NJ (2005) Temozolomide pharmacodynamics in patients with metastatic melanoma: dna damage and activity of repair enzymes O6-alkylguanine alkyltransferase and poly(ADP-ribose) polymerase-1. Clin Cancer Res 11:3402-3409
16. Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, Bell-McGuinn KM, Scott C, Weitzel JN, Oaknin A, Loman N, Lu K, Schmutzler RK, Matulonis U, Wickens M, Tutt A (2010) Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet 376:245-251
17. Fong PC, Yap TA, Boss DS, Carden CP, Mergui-Roelvink M, Gourley C, De Greve J, Lubinski J, Shanley S, Messiou C, A'Hern R, Tutt A, Ashworth A, Stone J, Carmichael J, Schellens JHM, de Bono JS, Kaye SB (2010) Poly(ADP)-ribose polymerase inhibition: frequent durable responses in BRCA carrier ovarian cancer correlating with platinum-free interval. J Clin Oncol 28:2512-2519
18. Gelmon KA, Tischkowitz M, Mackay H, Swenerton K, Robidoux A, Tonkin K, Hirte H, Huntsman D, Clemons M, Gilks B, Yerushalmi R, MacPherson E, Carmichael J, Oza A (2011) Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a Phase 2, multicentre, open-label, non-randomised study. Lancet Oncol 12:852-861
19. Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira Frommer R, Safra T, Matei D, MacPherson E, Watkins C, Carmichael J, Matulonis U (2012) Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 366:1382-1392
20. Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, Friedlander M, Arun B, Loman N, Schmutzler RK, Wardley A, Mitchell G, Earl H, Wickens M, Carmichael J (2010) Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet 376:235-244
21. Dent RA, Lindeman G, Clemons M, Wildiers H, Chan A, McCarthy NJ, Singer CF, Lowe ES, Kemlsey K, Carmichael J (2010) Safety and efficacy of the oral PARP inhibitor olaparib (AZD2281) in combination with paclitaxel for the first- or second-line treatment of patients with metastatic triple negative breast cancer: Results from the safety cohort of a Phase I/II multicenter trial. J Clin Oncol 28(15S):abst 1018