An Adaptive Study to Determine the Optimal Dose of the Tablet Formulation of the PARP Inhibitor Olaparib

Targeted Oncology

Volumn 11, Issue 3, 2016, Pages 401-415

  Mateo, J ^a   Moreno, V ^a   Gupta, A ^b   Kaye, S B ^a   Dean, E ^c   Middleton, M R ^b   Friedlander, M ^d   Gourley, C ^e   Plummer, R ^f   Rustin, G ^g   Sessa, C ^h   Leunen, K ⁱ   Ledermann, J ^j   Swaisland, H ^k   Fielding, A ^k   Bannister, W ^l   Nicum, S ^b   Molife, L R ^a  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b UNIVERSITY OF OXFORD   (United Kingdom)

^c CHRISTIE HOSPITAL   (United Kingdom)

^d UNIVERSITY OF NEW SOUTH WALES   (Australia)

^e UNIVERSITY OF EDINBURGH   (United Kingdom)

^f Northern Centre for Cancer Care   (United Kingdom)

^g MOUNT VERNON HOSPITAL   (United Kingdom)

^h ONCOLOGY INSTITUTE OF SOUTHERN SWITZERLAND   (Switzerland)

ⁱ UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^j UNIVERSITY COLLEGE LONDON   (United Kingdom)

^k ASTRAZENECA   (United Kingdom)

^l PHASTAR   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

OLAPARIB; NICOTINAMIDE ADENINE DINUCLEOTIDE ADENOSINE DIPHOSPHATE RIBOSYLTRANSFERASE INHIBITOR; PHTHALAZINE DERIVATIVE; PIPERAZINE DERIVATIVE;

ABDOMINAL PAIN; ADULT; ADVANCED CANCER; ANEMIA; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BACKACHE; BLOOD TOXICITY; BREAST CANCER; CASTRATION RESISTANT PROSTATE CANCER; COLORECTAL CANCER; CONSTIPATION; CONTROLLED STUDY; COUGHING; CROSSOVER PROCEDURE; DECREASED APPETITE; DIARRHEA; DRUG BIOAVAILABILITY; DRUG CAPSULE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSGEUSIA; DYSPNEA; ESOPHAGUS CARCINOMA; FATIGUE; FEMALE; GASTROINTESTINAL TOXICITY; GENE MUTATION; HUMAN; HYPERTRANSAMINASEMIA; INTESTINE OBSTRUCTION; KIDNEY CARCINOMA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MINIMUM PLASMA CONCENTRATION; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NEUTROPENIA; NONCARDIAC CHEST PAIN; OPEN STUDY; OPTIMAL DRUG DOSE; OVARY CANCER; PANCREAS CANCER; PATIENT COMPLIANCE; PERIPHERAL EDEMA; PERITONEUM CANCER; PHASE 1 CLINICAL TRIAL; PNEUMOCYSTIS PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; SINGLE DRUG DOSE; SMALL INTESTINE OBSTRUCTION; SOLID TUMOR; STOMACH CANCER; TABLET FORMULATION; THROMBOCYTOPENIA; TUMOR REGRESSION; TUMOR SUPPRESSOR GENE; URINARY TRACT INFECTION; UTERINE TUBE CARCINOMA; UTERUS SARCOMA; VOMITING; CLINICAL TRIAL;

FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; PHTHALAZINES; PIPERAZINES; POLY(ADP-RIBOSE) POLYMERASE INHIBITORS;

EID: 84966698996     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-016-0435-8     Document Type: Article

References (26)

1. Farmer H, McCabe N, Lord CJ, et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature. 2005;434:917–21.
2. Bryant HE, Schultz N, Thomas HD, et al. Specific killing of BRCA2-deficient tumours with inhibitors of poly(ADP-ribose) polymerase. Nature. 2005;434:913–7.
3. Pal T, Permuth-Wey J, Betts JA, et al. BRCA1 and BRCA2 mutations account for a large proportion of ovarian carcinoma cases. Cancer. 2005;104:2807–16.
4. Cancer Genome Atlas Research Network. Integrated genomic analyses of ovarian carcinoma. Nature. 2011;474:609–15.
5. Gonzalez-Angulo AM, Timms KM, Liu S, et al. Incidence and outcome of BRCA mutations in unselected patients with triple receptor-negative breast cancer. Clin Cancer Res. 2011;17:1082–9.
6. Hartman AR, Kaldate RR, Sailer LM, et al. Prevalence of BRCA mutations in an unselected population of triple-negative breast cancer. Cancer. 2012;118:2787–95.
7. Fong PC, Boss DS, Yap TA, et al. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009;361:123–34.
8. Audeh MW, Carmichael J, Penson RT, et al. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet. 2010;376:245–51.
9. Tutt A, Robson M, Garber JE, et al. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet. 2010;376:235–44.
10. Kaye SB, Lubinski J, Matulonis U, et al. Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer. J Clin Oncol. 2012;30:372–9.
11. Kaufman B, Shapira-Frommer R, Schmutzler RK, et al. Olaparib monotherapy in patients with advanced cancer and a germ-line BRCA1/2 mutation. J Clin Oncol. 2015;33:244–50.
12. Gelmon KA, Tischkowitz M, Mackay H, et al. 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. 2011;12:852–61.
13. Konstantinopoulos PA, Spentzos D, Karlan BY, et al. Gene expression profile of BRCAness that correlates with responsiveness to chemotherapy and with outcome in patients with epithelial ovarian cancer. J Clin Oncol. 2010;28:3555–61.
14. Michels J, Vitale I, Saparbaev M, et al. Predictive biomarkers for cancer therapy with PARP inhibitors. Oncogene. 2014;33:3894–907.
15. McCabe N, Turner NC, Lord CJ, et al. Deficiency in the repair of DNA damage by homologous recombination and sensitivity to poly(ADP-ribose) polymerase inhibition. Cancer Res. 2006;66:8109–15.
16. Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012;366:1382–92.
17. Ledermann J, Harter P, Gourley C, et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014;15:852–61.
18. AstraZeneca. Lynparza™ approved in the European Union as first-in-class treatment for advanced BRCA-mutated ovarian cancer. 2014. Available at: http://www.astrazeneca.com/Media/Press-releases/Article/20141218--lynparza-approved-in-the-european-union.
19. FDA. Olaparib. 2014. Available at: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm427598.htm.
20. AstraZeneca. Global Policy: Bioethics. 2015. Available at: http://www.astrazeneca.com/Responsibility/Code-policies-standards/Our-global-policies.
21. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–16.
22. Rustin GJ, Vergote I, Eisenhauer E, et al. Definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup (GCIG). Int J Gynecol Cancer. 2011;21:419–23.
23. Hennessy BT, Coleman RL, Markman M. Ovarian cancer. Lancet. 2009;374:1371–82.
24. Balmana J, Tung NM, Isakoff SJ, et al. Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors. Ann Oncol. 2014;25:1656–63.
25. Del Conte G, Sessa C, von Moos R, et al. Phase I study of olaparib in combination with liposomal doxorubicin in patients with advanced solid tumours. Br J Cancer. 2014;111:651–9.
26. Oza AM, Cibula D, Benzaquen AO, et al. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial. Lancet Oncol. 2015;16:87–97.