A phase I clinical and pharmacokinetic study of Ro 31-7453 given as a 7- or 14-day oral twice daily schedule every 4 weeks in patients with solid tumors

Clinical Cancer Research

Volumn 10, Issue 13, 2004, Pages 4374-4382

  Salazar, Ramon ^a,e   Bissett, Donald ^b   Twelves, Chris ^a,c,f   Breimer, Lars ^d   DeMario, Mark ^d   Campbell, Sophia ^a   Zhi, Jay ^d   Ritland, Steve ^d   Cassidy, Jim ^a,b  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b UNIVERSITY OF ABERDEEN   (United Kingdom)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d HOFFMANN LA ROCHE INC   (United States)

^e HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^f UNIVERSITY OF BRADFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMITOTIC AGENT; RO 31 7453; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BONE MARROW SUPPRESSION; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CARCINOMA; DERMATITIS; DIARRHEA; DOSE CALCULATION; DOSE RESPONSE; DRUG ABSORPTION; DRUG ACTIVITY; DRUG HALF LIFE; DRUG METABOLISM; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FLU LIKE SYNDROME; GASTROINTESTINAL SYMPTOM; HUMAN; LUNG CANCER; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; PANCYTOPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; SOLID TUMOR; STOMATITIS; THROMBOCYTOPENIA;

ADULT; AGED; ANTINEOPLASTIC AGENTS; AREA UNDER CURVE; CARCINOMA; COLORECTAL NEOPLASMS; DOSE-RESPONSE RELATIONSHIP, DRUG; EDETIC ACID; FEMALE; HUMANS; INDOLES; MALE; MIDDLE AGED; MODELS, CHEMICAL; NEOPLASMS; TIME FACTORS;

EID: 3042851771     PISSN: 10780432     EISSN: None     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-04-0135     Document Type: Article

References (18)

1. Ritland S, Ken R, Ke J, et al. Preclinical characterization of Ro 31-7453: a new cell cycle inhibitor in clinical development for solid tumors. Proc Am Assoc Cancer Res 2001;42:911.
2. Dhingra U, Ken R, Fishteyn D, et al. Characterization of in vitro antiproliferative activity of Ro 31-7453, a new cell-cycle inhibitor. Proc Am Assoc Cancer Res 2000;41:30.
3. Tamborini B, Bertasso A, Thomas M, et al. Enhanced antiproliferative and antitumor activity using Ro 31-7453 in combination with paclitaxel. Proc Am Assoc Cancer Res 2001;42:215.
4. Dhingra U, Luistro L, Mortensen J, et al. Ro 31-7453 has in vivo antitumor activity against human xenograft and syngenic tumor models. Proc Am Assoc Cancer Res 2000;41:34.
5. Dhingra U, Ke J, Kratzeisen C, et al. Preclinical characterization of a new cell cycle inhibitor Ro 31-7453. Proc Am Assoc Cancer Res 2000;41:34.
6. Dhingra U, Thomas M, Bertasso A, et al. Identification and preclinical characterization of metabolites of Ro 31-7453, a new cell-cycle inhibitor. Proc Am Assoc Cancer Res 2000;41:31.
7. Dhingra U, Mortensen JH, Luistro LL, Sampeur PS. Evaluation of effects of dose and schedule on efficacy and toxicity of orally administered Ro 31-7453 in tumor bearing nude mice. Proc Am Assoc Cancer Res 2000;41:34.
8. Shah N, Phuapradit W, Ke J, et al. Development of a novel oral drug delivery system for the cell cycle inhibitor Ro 31-7453; improved bioavailability and therapeutic index through prolonged exposure. Proc Am Assoc Cancer Res 2001;42:373.
9. Simon R, Freidlin B, Rubinstein L, et al. Accelerated titration designs for Phase I clinical trials in oncology. J Natl Cancer Inst (Bethesda) 1997;89:1138-47.
10. Terwogt JM, Schellens JH, Huinink WW, Beijnen JH. Clinical pharmacology of anticancer agents in relation to formulations and administration routes. Cancer Treat Rev 1999;25:83-101.
11. Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol 1997;15:110-5.
12. Soignet S, Bienvenu B, Breimer L, et al. A novel cell cycle inhibitor (Ro31-7453): a clinical and pharmacokinetic study in patients with solid tumors: final report of a 4-day q 3 weeks schedule. Proc Am Soc Clin Oncol 2001;20:88a.
13. Lee J, Soignet S, Cassidy J, et al. Clinical pharmacokinetics of Ro 31-7453, a novel cell cycle inhibitor in Phase I trials. Proc Am Assoc Cancer Res 2001;42:834.
14. Rahmani R, Martin M, Favre R, Cano JP, Barbet J. Clinical pharmacokinetics of vindesine: repeated treatments by intravenous bolus injections. Eur J Cancer Clin Oncol 1984;20:1409-17.
15. Rahmani R, Bruno R, Iliadis A, et al. Clinical pharmacokinetics of the antitumor drug navelbine (5′- noranhydrovinblastine). Cancer Res 1987;47:5796-9.
16. Kearns CM, Gianni L, Egorin MJ. Paclitaxel pharmacokinetics and pharmacodynamics. Semin Oncol 1995;22:16-23.
17. Nicolson M, Bisset D, Cassidy J, et al. A Phase I clinical and pharmacokinetic study of oral Ro 31-7453, a novel cell cycle inhibitor administered in combination with gemcitabine. Proc Am Assoc Cancer Res 2002;43:276.
18. Papadimitrakopoulou V, Henderson E, Breimer L, et al. A Phase I clinical and pharmacokinetic study of oral Ro 31-7453, a novel cell cycle inhibitor, administered in combination with paclitaxel. Proc Am Soc Clin Oncol 2002;21:6b.