Phase 1 first-in-human trial of the vascular disrupting agent plinabulin (NPI-2358) in patients with solid tumors or lymphomas

Clinical Cancer Research

Volumn 16, Issue 23, 2010, Pages 5892-5899

  Mita, Monica M ^a   Spear, Matthew A ^b   Yee, Lorrin K ^c   Mita, Alain C ^a   Heath, Elisabeth I ^d   Papadopoulos, Kyriakos P ^a   Federico, Kristine C ^b   Reich, Steven D ^b   Romero, Ofelia ^a   Malburg, Lisa ^d   Pilat, MaryJo ^d   Lloyd, G Kenneth ^b   Neuteboom, Saskia T C ^b   Cropp, Gillian ^b   Ashton, Edward ^e   LoRusso, Patricia M ^d  

^a CTRC Institute for Drug Development   (United States)

^b Nereus Pharmaceuticals Inc   (United States)

^c Northwest Medical Specialties   (United States)

^d KARMANOS CANCER INSTITUTE   (United States)

^e VirtualScopics LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLINABULIN;

ADULT; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ARTHRALGIA; ARTICLE; CANCER PAIN; CLINICAL ARTICLE; CLINICAL TRIAL; CONFUSION; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG HALF LIFE; DRUG SAFETY; DYSGEUSIA; DYSPNEA; FATIGUE; FEMALE; FEVER; HEADACHE; HUMAN; HYPERTENSION; HYPOKALEMIA; INFECTION; INSOMNIA; LYMPHOMA; MALE; NAUSEA; NUCLEAR MAGNETIC RESONANCE IMAGING; PERIPHERAL EDEMA; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SIDE EFFECT; SOLID TUMOR; TREATMENT RESPONSE; TUMOR BLOOD FLOW; VOMITING; WEIGHT REDUCTION; XEROSTOMIA;

ADULT; AGED; ANGIOGENESIS INHIBITORS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HALF-LIFE; HUMANS; IMIDAZOLES; INFUSIONS, INTRAVENOUS; LYMPHOMA; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; PILOT PROJECTS; PIPERAZINES;

EID: 78650376933     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-10-1096     Document Type: Article

References (21)

1. Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal cellcarcinoma.N Engl J Med 2007;356:115-24.
2. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small cell lung cancer. N Engl J Med 2006; 355:2542-50.
3. Denekamp J. Endothelial cell proliferation as a novel approach to targeting tumour therapy. Br J Cancer 1982;45:136-9. (Pubitemid 12207761)
4. Denekamp J. The current status of targeting tumour vasculature as a means of cancer therapy: An overview. Int J Radiat Biol 1991;60:401-8.
5. Shi W, Siemann DW. Targeting the tumor vasculature: enhancing antitumor efficacy through combination treatment with ZD6126 and ZD6474. In Vivo 2005;19:1045-50.
6. Nathan PD, Judson I, Padhani A, et al. A phase I study of combretastatin A4 phosphate (CA4P) and bevacizumab in subjects with advanced solid tumors [abstract]. J Clin Oncol 2008; 26Suppl: 3550.
7. McKeage MJ, Von Pawel J, Reck M, et al. Randomised phase II study of ASA404 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer. Br J Cancer 2008;99: 2006-12.
8. 2 combined with carboplatin and paclitaxel in previously untreated advanced non-small cell lung cancer. Lung Cancer 2009; 65:192-7.
9. Nicholson B, Lloyd GK, Miller BR, et al. NPI-2358 is a tubulin-depolymerizing agent: In-vitro evidence for activity as a tumor vascular-disrupting agent. Anticancer Drugs 2006;17:25-31.
10. Yamazaki Y, Kohno K, Yasui H, et al. Tubulin photoaffinity labeling with biotin-tagged derivatives of potent diketopiperazine antimicrotubule agents. Chembiochem 2008;9:3074-81.
11. Lloyd GK, Nicholson B, Neuteboom STC, , et al. NPI-2358: A new vascular/tubulin modifying agent greatly potentiates standard chemotherapy in xenograft models. EORTC-NCI-AACR Molecular Targets and Therapeutics Meeting, Boston, MA; 2003.
12. Neuteboom STC, Medina E, Palladino MA, et al. NPI-2358, A novel tumor vascular disrupting agent potentiates the anti-tumor activity of docetaxel in the non small cell lung cancer model MV522 [abstract]. Eur J Cancer 2008;6Suppl:141.
13. Therasse P, Arbuck SG, Eisenhauer EA, et al. New Guidelines to Evaluate the Response to Treatment in Solid Tumors. J Natl Cancer Inst 2000;92:205-16.
14. Cheson BD, Horning SJ, Coiffier B, et al. Report of an International Workshop to standardize response criteria for non-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-53.
15. Heist R, Aren O, Millward M, et al. Phase 1/2 study of the vascular disrupting agent (VDA) plinabulin (NPI-2358) combined with docetaxel in patients with non-small cell lung cancer (NSCLC) [abstract]. Mol Cancer Ther 2009;8Suppl:C30.
16. Rustin GJS, Galbraith SM, Anderson H, et al. Phase I clinical trial of weekly combretastatin A4 phosphate: Clinical and pharmacokinetic Results. J Clin Oncol 2003;21:2815-22. (Pubitemid 46621828)
17. Tozer GM, Prise VE, Wilson J, et al. Combretastatin A-4 Phosphate as a tumor vascular-targeting agent: early effects in tumors and normal tissues. Cancer Res 1999;59:1626-34. (Pubitemid 29160136)
18. Zweifel M, Jayson G, Reed N, et al. Combretastatin A-4 phosphate (CA4P) carboplatin and paclitaxel in patients with platinum-resistant ovarian cancer: Final phase II trial results [abstract]. J Clin Oncol 2009;27Suppl:5502.
19. Sessa C, Lorusso P, Tolcher AW, et al. A pharmacokinetic and DCE-MRI-dynamic Phase I study of the antivascular combretastatin analogue AVE8062A administered every 3 weeks [abstract]. Amer Assoc Cancer Res 2005;46:1371.
20. Kurzrock R, Akerley W, Hong D, et al. Two phase 1 studies of MPC-6827, a novel vascular disrupting agent (VDA), in patients with advanced solid tumors and CNS metastases [abstract]. J Clin Oncol 2007;25Suppl:3604.
21. Millward M, Mita A, Spear MA, et al. Phase I trial of NPI-2358 (a novel vascular disrupting agent) plus docetaxel [abstract]. J Clin Oncol 2009;27Suppl:3571.