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  • 1
    Electronic Resource
    Electronic Resource
    Phase I pharmacokinetic study of DUP-937, a new anthrapyrazole (1993)
    Springer
    Investigational new drugs 11 (1993), S. 301-308 
    Details
    ISSN: 1573-0646
    Keywords: anthrapyrazole ; DUP-937 ; phase I ; pharmacokinetics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary DUP-937 is a new anthrapyrazole intercalator that inhibits DNA synthesis. A phase I trial was conducted in which DUP-937 was given in an intravenous bolus weekly for 3 weeks. Cycles were repeated every 5 weeks. Twenty men and 13 women with median ECOG performance status of 1 completed 74 cycles. The starting dose was 0.55 mg/m2/week and doses were escalated to 16 mg/m2/week. Non-hematological toxicity was generally mild or moderate and consisted mainly of gastro-intestinal effects, fatigue, alopecia and local-reactions. Grade 3 neutropenia was first documented at 7.36 mg/m2 and became more common at higher dose levels. Three of four patients had ≥ grade 3 neutropenia at the 16 mg/m2 dose level. Thrombocytopenia was minimal. The dose-limiting toxicity was neutropenia and the maximum tolerated dose was 16 mg/m2 weekly for 3 weeks. Mean area under the curve (AUC) values increased with dose. Linear pharmacokinetics were observed as total body clearance (CLtb), half-life (t1/2) and volume of distribution (Vss) did not change with increasing doses. One partial remission in a patient with prostate carcinoma was documented.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00874428
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  • 2
    Electronic Resource
    Electronic Resource
    Phase I study of oral menogaril administered on a once weekly schedule (1990)
    Springer
    Investigational new drugs 8 (1990), S. 43-52 
    Details
    ISSN: 1573-0646
    Keywords: menogarilm ; phase I ; oral chemotherapy ; weekly chemotherapy
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Forty-seven patients with solid tumors were treated on a phase I study of menogaril administered by mouth once per week. Nausea and vomiting were excessive at weekly doses of 350 and 450 mg/m2/week but were tolerable and controlled reasonably well by antiemetics at lower doses. There appeared to be a relatively shallow dose-vs-granulocytopenia curve above a menogaril dose of 180 mg/m2/week. No patient receiving chronic dexamethasone for cerebral edema developed granulocytopenia, even at menogaril doses of 350–450 mg/m2/week. Two patients developed neutropenic infection. No patient developed thrombocytopenia. Mild arrhythmias were seen in 3 patients. Two patients suffered possible myocardial infarcts that may not have been related to treatment. Asymptomatic blood pressure fluctuations were common and were probably not related to treatment. Diarrhea was dose-related but was generally not severe. Alopecia and stomatitis occurred occasionally. Minor responses were seen in two patients with gliomas, and three of five evaluable prostate cancer patients experienced marked pain relief. The dose recommended for phase II studies is 250–300 mg/m2/week with antiemetic pretreatment. This schedule appears to allow an oral menogaril doseintensity that is approximately double that attainable with other oral schedules that have been studied.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00216923
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  • 3
    Electronic Resource
    Electronic Resource
    Clinical pharmacology of tiazofurin (2-β-D-ribofuranosylthiazole-4-carboxamide, NSC 286193) (1986)
    Springer
    Investigational new drugs 4 (1986), S. 387-394 
    Details
    ISSN: 1573-0646
    Keywords: tiazofurin ; pharmacology ; phase I
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract A pharmacokinetic study of tiazofurin was carried out in 13 patients treated in a phase I clinical trial of the drug and in 7 patients undergoing surgical resection of brain tumor (in conjunction with studies on penetration of drug into central nervous system tumors). Tiazofurin was found to be rapidly eliminated from the plasma and red blood cell fraction of both groups of patients with kinetics consistent with a two-compartment model of elimination. Operative conditions did not significantly change the pharmacokinetics of tiazofurin in CNS patients. Pharmacokinetics were linear over the dose range 500–2700 mg/m2. The data suggest that there is only a small degree of tissue binding of drug and that the drug is not concentrated by tissues. Uptake into RBC was rapid and elimination from RBC was essentially parallel to drug elimination from plasma. There was no evidence that RBC sequestration of drug contributes to toxicity. Much of the drug was excreted unchanged in the urine, but there was little correlation between creatinine clearance and plasma pharmacokinetics of tiazofurin, suggesting that renal tubular secretion may be a more important method of elimination than is glomerular filtration. Patients with high AUC values and low plasma clearance values were particularly prone to develop toxicity.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00173513
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  • 4
    Electronic Resource
    Electronic Resource
    Phase I study of idarubicin administered orally on a daily × 3 schedule (1990)
    Springer
    Investigational new drugs 8 (1990), S. 275-281 
    Details
    ISSN: 1573-0646
    Keywords: idarubicin ; phase I ; oral
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Twenty-one adult patients with refractory solid tumors were treated on a phase I study of idarubicin (4-demethoxydaunorubicin) administered daily for 3 days every 3 weeks. Nineteen of the patients had received previous chemotherapy (including 13 with prior anthracyclines), and 12 had received prior radiotherapy. Idarubicin dose levels of 10, 15, 17.5, 20, and 25 mg/m2 were explored. Hematological toxicity was dose-related. Other toxicity was acceptable. Only one patient (treated with an idarubicin dose of 17.5 mg/m2/day) developed neutropenic fever, from which he recovered. Further dose escalations beyond 25 mg/m2 were not carried out because of the increasing length of time required for recovery from granulocytopenia at higher doses. No patient experienced a major response, but minor responses were seen in 3 patients with carcinomas of the colon, breast, and kidney respectively. Further phase II studies of oral idarubicin at a starting dose of 20–25 mg/m2 daily times 3 days in patients with good bone marrow reserves are recommended. Because of the degree of neutropenia expected, patients would have to be observed carefully.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00171837
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