Multicentric parallel phase II trial of the polo-like kinase 1 inhibitor BI 2536 in patients with advanced head and neck cancer, breast cancer, ovarian cancer, soft tissue sarcoma and melanoma. the first protocol of the European Organization for Research and Treatment of Cancer (EORTC) Network of Core Institutes (NOCI)

European Journal of Cancer

Volumn 46, Issue 12, 2010, Pages 2206-2215

  Schöffski, Patrick ^a   Blay, Jean Yves ^b   De Greve, Jacques ^c   Brain, Etienne ^d   MacHiels, Jean Pascal ^e   Soria, Jean Charles ^f   Sleijfer, Stefan ^g   Wolter, Pascal ^a   Ray Coquard, Isabelle ^b   Fontaine, Christel ^c   Munzert, Gerd ^h   Fritsch, Holger ^h   Hanft, Gertraud ^h   Aerts, Claire ⁱ   Rapion, Jérome ⁱ   Allgeier, Anouk ⁱ   Bogaerts, Jan ⁱ   Lacombe, Denis ⁱ  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b UNIVERSITÉ LYON 1   (France)

^c UNIVERSITY HOSPITAL BRUSSELS   (Belgium)

^d CENTRE RENÉ HUGUENIN   (France)

^e UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^f INSTITUT GUSTAVE ROUSSY   (France)

^g ERASMUS MEDICAL CENTER   (Netherlands)

^h BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

ⁱ EORTC DATA CENTER   (Belgium)

Author keywords

BI 2536; Breast cancer; Head and neck cancer; Melanoma; Ovarian cancer; Phase II trial; PLK; Polo like kinase inhibitor; Small molecule; Soft tissue sarcoma

Indexed keywords

4 (8 CYCLOPENTYL 7 ETHYL 5,6,7,8 TETRAHYDRO 5 METHYL 6 OXO 2 PTERIDINYLAMINO) 3 METHOXY N (1 METHYL 4 PIPERIDINYL)BENZAMIDE; ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATININE;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTICLE; BONE MARROW; BREAST CANCER; CANCER SURVIVAL; CLINICAL TRIAL; CONSTIPATION; COUGHING; DISEASE COURSE; DIZZINESS; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; EDEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; HEAD AND NECK CANCER; HUMAN; INFECTION; KIDNEY FUNCTION; LIVER FUNCTION; MAJOR CLINICAL STUDY; MALE; MELANOMA; MUCOSA INFLAMMATION; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; OVARY CANCER; OVERALL SURVIVAL; PAIN; PERFORMANCE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PRURITUS; SENSORY NEUROPATHY; SIDE EFFECT; SINUS BRADYCARDIA; SOFT TISSUE SARCOMA; THROMBOCYTOPENIA; TREATMENT REFUSAL; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

ADULT; AGED; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; FEASIBILITY STUDIES; FEMALE; HEAD AND NECK NEOPLASMS; HUMANS; INFUSIONS, INTRAVENOUS; MALE; MELANOMA; MIDDLE AGED; NEOPLASMS; OVARIAN NEOPLASMS; PATIENT COMPLIANCE; PTERIDINES; SARCOMA; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77955714290     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2010.03.039     Document Type: Article

References (22)

1. P. Schöffski Polo-like kinase (PLK) inhibitors in preclinical and early clinical development in oncology Oncologist 14 6 2009 559 570
2. T.L. Schmit, and N. Ahmad Regulation of mitosis via mitotic kinases: new opportunities for cancer management Mol Cancer Therapy 6 2007 1920 1931
3. K. Strebhardt, and A. Ullrich Targeting polo-like kinase 1 for cancer therapy Nat Rev Cancer 6 2006 321 330
4. M. Steegmaier, M. Hoffmann, and A. Baum BI 2536, a potent and selective inhibitor of polo-like kinase 1, inhibits tumor growth in vivo Curr Biol 17 Suppl S2 2007 316 322
5. P.M. Ellis, Q.S. Chu, and N.B. Leighl A phase I dose escalation trial of BI 2536, a novel Plk1 inhibitor, with standard dose pemetrexed in previously treated advanced or metastatic non-small cell lung cancer (NSCLC) J Clin Oncol 26 2008 8115
6. R. Hofheinz, A. Hochhaus, and S. Al-Batran A phase I repeated dose escalation study of the Polo-like kinase 1 inhibitor BI 2536 in patients with advanced solid tumors J Clin Oncol 24 Suppl 18 2006 88s [abstract]
7. K. Mross, A. Frost, and S. Steinbild Phase I dose escalation and pharmacokinetic study of BI 2536, a novel polo-like kinase 1 inhibitor, in patients with advanced solid tumors J Clin Oncol 26 2008 5511 5517
8. P. Therasse, S.G. Arbuck, and E.A. Eisenhauer New guidelines to evaluate the response to treatment in solid tumors J Natl Cancer Inst 92 3 2000 205 216
9. R. Simon Optimal two-stage designs for phase II clinical trials Controlled Clin Trials 10 1989 1 10
10. J. Von Pawel, M. Reck, and W. Digel Randomized phase II trial of two dosing schedules of BI 2536, a novel Plk-1 inhibitor, in patients with relapsed advanced or metastatic non-small-cell lung cancer (NSCLC) J Clin Oncol 26 2008 8030
11. H.S. Pandha, A. Protheroe, and J. Wylie An open label phase II trial of BI 2536, a novel Plk1 inhibitor, in patients with metastatic hormone refractory prostate cancer (HRPC) J Clin Oncol 26 2008 14547
12. Mross K, Dittrich C, Aulitzky WE, et al. A randomized phase II trial of the novel polo-like kinase 1 inhibitor BI 2536 in chemonaïve patients with unresectable advanced pancreatic cancer - a study in cooperation with the CESAR network of investigators. In: Presented at the 33rd annual congress of the European Society for Medical Oncology, September 12-16, 2008, Stockholm, Sweden.
13. Schöffski P, Awada A, Dumez H, et al. A phase I single dose escalation study of the novel polo-like kinase I inhibitor BI 6727 in patients with advanced solid tumors. In: Presented at the 20th European Organization for Research and Treatment of Cancer - National Cancer Institute - American Association for Cancer Research symposium on molecular targets and cancer therapeutics, October 21-24, 2008, Geneva, Switzerland.
14. D. Rudolph, M. Steegmaier, and M. Hoffmann BI 6727, a polo-like kinase inhibitor with improved pharmacokinetic profile and broad antitumor activity Clin Can Res 15 9 2009 3094 3102
15. J.M. Weinstein, M.H. Ghalib, and M. Kumar Phase I study of ON 01910.Na, a novel polo-like kinase 1 pathway modulator, administered as a weekly 24-h continuous infusion in patients with advanced cancer J Clin Oncol 26 2008 2515
16. L.L. Garland, C. Taylor, and D.L. Pilkington A phase I pharmacokinetic study of HMN-214, a novel oral stilbene derivative with Polo-like kinase-1-interacting properties, in patients with advanced solid tumors Clin Can Res 12 2006 5182 5189
17. D.D. Von Hoff, C. Taylor, and S. Rubin A phase I and pharmacokinetic study of HMN-214, a novel oral Polo-like kinase inhibitor, in patients with advanced solid tumors J Clin Oncol 22 Suppl 14 2004 3034
18. Blagden S, Olmos D, Sharma R, et al. A phase I first-in-human study of the polo-like kinase 1-selective inhibitor, GSK461364, in patients with advanced solid tumors. In: Presented at the 20th European Organization for Research and Treatment of Cancer - National Cancer Institute - American Association for Cancer Research symposium on molecular targets and cancer therapeutics, October 21-24, 2008, Geneva, Switzerland.
19. Chapman CM, Perez-Galan P, Wiestner A. ON 01910.Na, a novel clinical grade PLK-1 inhibitor, selectively induces apoptosis in human B-cell chronic lymphocytic leukemia (B-CLL). In: Presented at the American Association of Cancer Research 2009 annual meeting, April 18-22, 2009, Denver, CO.
20. A. Patnaik, L. Forero, and A. Goetz HMN-214, a novel oral antimicrotubular agent, inhibitor of Polo-like-and cyclin-dependent kinases: clinical, pharmacokinetic (PK), pharmacodynamic (PD) relationships observed in a phase I trial of a daily × 5 schedule every 28 days Proc Am Soc Clin Oncol 22 2003 514 [abstract]
21. T. Ohnuma, S.Y. Cho, and J. Roboz Phase I study of ON 01910.Na by 3-day continuous infusion (CI) in patients (pts) with advanced cancer J Clin Oncol 24 Suppl 18 2006 13137
22. R.C. Donehower, A. Jimeno, and J. Li Phase I study of ON 01910.Na, a novel cell cycle inhibitor in adult patients with solid tumors J Clin Oncol 24 Suppl 18 2006 13026