Population pharmacokinetics and dynamics in phase II studies of the novel bioreductive alkylating cytotoxic indoloquinone EO9

Anti-Cancer Drugs

Volumn 12, Issue 7, 2001, Pages 583-590

  Schellens, J H M ^a   Dombernowsky, P ^b   Cassidy, J ^c   Epelbaum, R ^d   Dirix, L ^e   Cox, E H ^a   Wanders, J ^f   Calabresi, F ^g   Paridaens, R ^h   Monfardini, S ⁱ   Wolff, J ^j   Loos, W J ^k   Verweij, J ^k   Pavlidis, N ^l   Hanauske, A R ^m  

^a NETHERLANDS CANCER INSTITUTE   (Netherlands)

^b Mental Health Services CPH   (Denmark)

^c UNIVERSITY OF GLASGOW   (United Kingdom)

^d RAMBAM MEDICAL CENTER   (Israel)

^e ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^f NDDO Oncology   (Netherlands)

^g REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^h UNIVERSITY HOSPITALS LEUVEN   (Belgium)

ⁱ CENTRO DI RIFERIMENTO ONCOLOGICO   (Italy)

^j Medizinische Klinik   (Germany)

^k ERASMUS MEDICAL CENTER   (Netherlands)

^l UNIVERSITY OF IOANNINA   (Greece)

^m TECHNICAL UNIVERSITY OF MUNICH   (Germany)

more..

Author keywords

Bayesian algorithm; EO9; Pharmacodynamics; Pharmacokinetics; Phase II; Population analysis

Indexed keywords

5 (1 AZIRIDINYL) 3 HYDROXYMETHYL 2 (3 HYDROXY 1 PROPENYL) 1 METHYL 4,7 INDOLEDIONE; ALKYLATING AGENT; CYTOTOXIC AGENT; INDOLOQUINONE; QUINONE DERIVATIVE; UNCLASSIFIED DRUG;

ADULT; AGED; ALGORITHM; AREA UNDER THE CURVE; ARTICLE; CANCER CHEMOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG CLEARANCE; DRUG EXPOSURE; DRUG RESPONSE; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; AZIRIDINES; FEMALE; HUMANS; INDOLEQUINONES; INDOLES; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; NEOPLASMS; POPULATION DYNAMICS; PROSPECTIVE STUDIES; SAMPLING STUDIES;

EID: 17944368505     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001813-200108000-00004     Document Type: Article

References (24)

1. Mitomycin C analogues 1. Indologuinoes as potential bisalkylating agents
2. EO9: A novel bioreductive alkylating indoloquinone with preferential solid tumour activity and lack of bone marrow toxicity in preclinical models
3. The role of human and rodent DT-diaphorase in the reductive metabolism of hypoxic cell cytotoxins
4. DT-diaphorase acticitiy correlates with sensitivity to the indoloquinone EO9 in mouse and human colon carcinomas
5. DT-diaphorase and cancer chemotherapy
6. The role of NAD(P)H: Quinone reductse (EC 1.6.99.2, DT-diaphorase) in the reductive bioactiviation of the novel indoloquinone antitumor agent EO9
7. The experimental development of bioreductive drugs and their role in cancer therapy
8. Role of NADPH: Cytochrome c reductase and DT-diaphorase in the biotranformation of mitomycin C
9. Pharmacokinetics, distribution, and metabolism of the novel bioreductive alkylating indoloquinone EO9 in rodents
10. Relative importance of DT-diaphorase and hypoxia in the bioactivation of EO9 by human lung tumor cell lines
11. Phase I and pharmacologic study of the novel indoloquinone bioreductive alkylating cytotoxic drug EO9
12. Clinical studies with EO9, a new indoloquinone bioreductive alkylating cytotoxic agent
13. Phase I pharmacokinetics and limited sampling strategies for the bioreductive alkylating drug EO9
14. Phase I study of the bioreductive indoloquinone EO9
15. Conference report: Opportunies for integration of pharmacokinetics, pharmacodynamics and toxicokinetics in rational drug development
16. The use of population pharmacokinetics in drug development
17. A population pharmacokinetic model for docetaxel (Taxotere): Model building and validation
18. A randomized phase II study with two schedules of the novel indoloquinone EO9 in non-small-cell lung cancer: A study of the EORTC Early Clinical Studies Group (ECSG)
19. EO9 phase II study in advanced breast, gastric, pancreatic and colorectal carcinoma by the EORTC Early Clinical Studies Group
20. Sensitive isocratic high-performance liquid chromatographic determination of a novel indoloquinone cytotoxic drug (EO9) in human plasma and urine
21. Some suggestions for measuring predictive performance
22. Phase I trial with weekly EO9, a novel bioreductive alkylating indoloquinone, by the EORTC Early Clinical Study Group (ECSG)
23. Is dose normalization to weight or body surface area useful in adults