Biomaterial Database

Phase I trial of N-methylformamide. 1984

J G McVie, and W W ten Bokkel Huinink, and G Simonetti, and R Dubbelman

N-methylformamide was administered iv and later orally to 19 patients in a phase I study, with a starting dose of 300 mg/m2/day X 5. The cycles were planned to be repeated every 2 weeks, and doses were escalated in four steps to 1200 mg/m2/day X 5. The principal toxic effect of the drug was nausea and vomiting, but this was not severe enough to interfere with oral medication. Parallel bioavailability studies confirmed excellent absorption of the drug. Biochemical disturbances included reversible elevation in transaminases not related to dose, peripheral neuropathy in one patient, and drug interaction with alcohol in another. The dose-limiting toxic effect was reversible hyperbilirubinemia. One patient became jaundiced. Among 15 evaluable patients, there were two partial responses (prostate and cervix carcinoma) and two minimal responses (ovarian carcinoma and hypernephroma). The recommended dose for the phase II study is 800 mg/m2/day X 5 orally, repeated every 2 or 3 weeks.

UI	MeSH Term	Description	Entries
D008099	Liver	A large lobed glandular organ in the abdomen of vertebrates that is responsible for detoxification, metabolism, synthesis and storage of various substances.	Livers
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009325	Nausea	An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.
D009369	Neoplasms	New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.	Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D010523	Peripheral Nervous System Diseases	Diseases of the peripheral nerves external to the brain and spinal cord, which includes diseases of the nerve roots, ganglia, plexi, autonomic nerves, sensory nerves, and motor nerves.	Peripheral Nerve Diseases,Peripheral Neuropathies,PNS (Peripheral Nervous System) Diseases,PNS Diseases,Peripheral Nervous System Disease,Peripheral Nervous System Disorders,Nerve Disease, Peripheral,Nerve Diseases, Peripheral,Neuropathy, Peripheral,PNS Disease,Peripheral Nerve Disease,Peripheral Neuropathy
D004334	Drug Administration Schedule	Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience.	Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
D004341	Drug Evaluation	Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals.	Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260	Female		Females
D005559	Formamides	A group of amides with the general formula of R-CONH2.