Phase I dose-escalation and pharmacokinetic study of a novel folate analogue AG2034

2001

Study of a New Cancer Drug AG2034

Sample size: 28 publication Evidence: low

Author Information

Author(s): Bissett D, McLeod H L, Sheedy B, Collier M, Pithavala Y, Paradiso L, Pitsiladis M, Cassidy J

Primary Institution: Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen, UK

Can the novel folate analogue AG2034 be safely administered to patients with intractable cancers?

The study found that AG2034 can be administered safely at a maximum tolerated dose of 5 mg/m2, but no objective antitumor responses were observed.

AG2034 was administered as a short intravenous infusion once every 3 weeks.
Dose-limiting toxicities included mucositis, diarrhoea, and vomiting at doses of 6 mg/m2 and above.
The maximum tolerated dose was determined to be 5 mg/m2.
Pharmacokinetic analysis showed evidence of drug accumulation with increasing doses.

Researchers tested a new cancer drug called AG2034 on 28 patients, but while it was safe to use, it didn't help shrink tumors.

Phase I dose-escalation study with 28 patients receiving AG2034 as an intravenous infusion every 3 weeks.

No objective antitumor responses were observed, and the study was limited to a small sample size.

Patients had histologically proven intractable cancers.

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