zd-9331 and Stomach-Neoplasms

zd-9331 has been researched along with Stomach-Neoplasms* in 2 studies

Trials

2 trial(s) available for zd-9331 and Stomach-Neoplasms

ArticleYear
Phase I dose-escalation trial of ZD9331 in Japanese patients with refractory, solid malignancies.
    Anti-cancer drugs, 2003, Volume: 14 Suppl 1

    ZD9331 is a novel thymidylate synthase inhibitor that, unlike some other antifolates, does not require polyglutamation for activity. This phase I dose-escalation trial investigated the tolerability, efficacy and pharmacokinetics of ZD9331 in Japanese patients with refractory, solid malignancies.. The mean age of patients was 57.6 years, and the most common primary tumours were gastric and colorectal cancer. Most patients had received prior chemotherapy and/or surgery. ZD9331 (69, 108 and 130 mg/m2/day) was administered as a 30-min i.v. infusion on days 1 and 8 of a 3-week cycle.. A total of 18 patients received ZD9331 treatment; six at each dose level. Patients received a median of 2 cycles of treatment ZD9331 demonstrated some antitumour activity, with one-third of patients showing no significant change in tumour size. ZD9331 was associated with non-dose-dependent myelosuppression, and dose-limiting toxicity was observed in one patient given 69 mg/m2/day and one patient given 130 mg/m2/day. The maximum plasma concentration and total area under the concentration-time curve increased with ZD9331 dose, whereas other pharmacokinetic parameters remained constant and independent of dose. Pharmacokinetic parameters were comparable following day 1 and 8 doses, with no accumulation of ZD9331 following the second dose.. ZD9331 has a manageable toxicity profile and shows some evidence of activity in Japanese patients with refractory, solid malignancies. The pharmacokinetic profile of ZD9331 in Japanese patients is similar to that observed in Western patients.

    Topics: Adult; Colorectal Neoplasms; Drug Tolerance; Female; Humans; Japan; Male; Middle Aged; Neoplasms; Quinazolines; Stomach Neoplasms

2003
Phase II multicentre trial of ZD9331 monotherapy as first-line treatment for gastric cancer.
    Anti-cancer drugs, 2003, Volume: 14 Suppl 1

    ZD9331 is a novel, direct-acting and specific inhibitor of thymidylate synthase that has shown clinical activity and manageable tolerability in solid tumours. This phase II trial was designed to determine the antitumour activity and tolerability of ZD9331 given as a first-line therapy to patients with advanced gastric cancer.. Eligible patients who were chemonaïve with histologically or cytologically proven gastric cancer entered an open-label, multicentre, two-stage trial. Initially, patients were dosed at 130 mg/m2 (Regimen 1); however, following a protocol amendment, the starting dose was reduced to 65 mg/m2 (Regimen 2). Patients received ZD9331 as a 30-min i.v. infusion once weekly for 2 weeks followed by 1 week without treatment (3-week cycle).. Twenty-nine patients with advanced, relapsed or inoperable gastric cancer were recruited from 11 centres across Europe. Five patients (17.2%), all from Regimen 2, showed a partial response and 16 patients (55.2%) had a best response of disease stabilisation. Most patients (72.4%) had a best response of disease control with median time to progression being 98 days. ZD9331 had manageable toxicity with the most frequently reported adverse events being neutropenia (62%) and diarrhoea (38%).. ZD9331, as a first-line treatment for patients with advanced gastric cancer, demonstrated clinical activity and manageable toxicity.

    Topics: Abdominal Pain; Antineoplastic Agents; Diarrhea; Drug Tolerance; Hematologic Diseases; Humans; Multicenter Studies as Topic; Neutropenia; Quinazolines; Stomach Neoplasms; Thymidylate Synthase

2003
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