Phase 1, open-label, dose escalation, safety, and pharmacokinetics study of ME-344 as a single agent in patients with refractory solid tumors

Cancer

Volumn 121, Issue 7, 2015, Pages 1056-1063

  Bendell, Johanna C ^a,b   Patel, Manish R ^a,c   Infante, Jeffrey R ^a,b   Kurkjian, Carla D ^a,d   Jones, Suzanne F ^a   Pant, Shubham ^a,d   Burris, Howard A ^a,b   Moreno, Ofir ^e   Esquibel, Vanessa ^e   Levin, Wendy ^e   Moore, Kathleen N ^a,d  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b Tennessee Oncology PLLC   (United States)

^c SARAH CANNON RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF OKLAHOMA   (United States)

^e Pharmaceuticals Inc   (United States)

Author keywords

first in human; maximum tolerated dose (MTD); ME 344; mitochondrial inhibitor; phase 1; refractory solid tumors

Indexed keywords

ANTINEOPLASTIC AGENT; ME 344; UNCLASSIFIED DRUG; ISOFLAVONE DERIVATIVE; ME-344;

ADULT; AGED; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; BLADDER CANCER; BREAST CANCER; CANCER CONTROL; CANCER PATIENT; CARCINOID; CARDIOTOXICITY; CENTRAL NERVOUS SYSTEM DISEASE; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COLORECTAL CARCINOMA; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DRUG ACCUMULATION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG FATALITY; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ENDOMETRIUM CANCER; FATIGUE; FEMALE; HEART INFARCTION; HUMAN; HUMAN TISSUE; HYPERTENSION; ILEUM CANCER; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; MONOTHERAPY; MOTOR NEUROPATHY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROPATHY; NON SMALL CELL LUNG CANCER; OPEN STUDY; OUTCOME ASSESSMENT; OVARY CARCINOMA; PANCREAS CANCER; PERIPHERAL NEUROPATHY; PERITONEUM CANCER; PHASE 1 CLINICAL TRIAL; PRIMARY TUMOR; PRIORITY JOURNAL; QT PROLONGATION; SARCOMA; SENSORY NEUROPATHY; SINUS BRADYCARDIA; SMALL CELL LUNG CANCER; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; ST SEGMENT ELEVATION MYOCARDIAL INFARCTION; TRANSITIONAL CELL CARCINOMA; TREATMENT DURATION; TREATMENT RESPONSE; UTERINE CERVIX CANCER; UTERUS SARCOMA; VAGINA CARCINOMA; CANCER STAGING; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECTS; FOLLOW UP; INTRAVENOUS DRUG ADMINISTRATION; MIDDLE AGED; MITOCHONDRION; MULTICENTER STUDY; NEOPLASMS; PATHOLOGY; PROGNOSIS; SAFETY; TISSUE DISTRIBUTION; VERY ELDERLY; YOUNG ADULT;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFUSIONS, INTRAVENOUS; ISOFLAVONES; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MITOCHONDRIA; NEOPLASM STAGING; NEOPLASMS; PROGNOSIS; SAFETY; TISSUE DISTRIBUTION; YOUNG ADULT;

EID: 84925348929     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.29155     Document Type: Article

References (13)

1. Alvero AB, Montagna MK, Chen R, et al. NV-128, a novel isoflavone derivative, induces caspase-independent cell death through the Akt/mammalian target of rapamycin pathway. Cancer. 2009; 115: 3204-3216.
2. Alvero AB, Montagna MK, Holmberg JC, Craveiro V, Brown D, Mor G,. Targeting the mitochondria activates two independent cell death pathways in the ovarian cancer stem cells. Mol Cancer Ther. 2011; 10: 1385-1393.
3. Alvero AB, Sumi N, Craveiro V, et al. ME-344 delays tumor kinetics in an ovarian cancer in vivo recurrence model [abstract]. Cancer Res. 2013; 73: Page. Abstract LB-286.
4. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guidelines (version 1.1). Eur J Cancer. 2009; 45: 228-247.
5. National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). Version 4.03. Washington, DC: US Department of Health and Human Services; 2010.
6. Xiao WH, Bennett GJ,. Effects of mitochondrial poisons on the neuropathic pain produced by the chemotherapeutic agents, paclitaxel and oxaliplatin. Pain. 2012; 153: 704-709.
7. Toyama S, Shimoyama N, Ishida Y, Koyasu T, Szeto HH, Shimoyama M,. Characterization of acute and chronic neuropathies induced by oxaliplatin in mice and differential effects of a novel mitochondria-targeted antioxidant on the neuropathies. Anesthesiology. 2014; 120: 459-473.
8. Areti A, Yerra VG, Naidu V, Kumar A,. Oxidative stress and nerve damage: role in chemotherapy induced peripheral neuropathy. Redox Biol. 2014; 2: 289-295.
9. Valentin-Vega YA, MacLean KH, Tait-Mulder J, et al. Mitochondrial dysfunction in ataxia-telangiectasia. Blood. 2012; 119: 1490-1500.
10. Copeland WC,. Defects in mitochondrial DNA replication and human disease. Crit Rev Biochem Mol Biol. 2012; 47: 64-74.
11. Sykora P, Croteau DL, Bohr VA, Wilson DM 3rd,. Aprataxin localizes to mitochondria and preserves mitochondrial function. Proc Natl Acad Sci USA. 2011; 108: 7437-7442.
12. Pant S, Burris H 3rd, Moore K, et al. A first-in-human dose-escalation study of ME-143, a second generation NADH oxidase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2014; 32: 87-93.
13. GlaxoSmithKline. Topotecan UP Package Insert. Brentford, UK: GlaxoSmithKline; 2014. gsksource.com/gskprm/en/US/adirect/gskprm?cmd=ProductDetailPage&product-id=1342013985525&featureKey=603583#nlmhighlightsD. Accessed on October 29, 2014.