Phase I study of RP 49532A, a new protein-synthesis inhibitor, in patients with advanced refractory solid tumors

Giroline (RP 49532A) is a new protein-synthesis inhibitor with broad antitumor activity in experimental models. In the present phase I study, Giroline was given by 24-h i.v. infusion every 3 weeks at doses ranging from 3 to 15 mg/m2 to 12 patients with advanced refractory solid tumors. The dose-limi...

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Bibliographic Details
Published in:Cancer chemotherapy and pharmacology 1995-01, Vol.35 (3), p.246-248
Main Authors: CATIMEL, G, COQUARD, R, GUASTALLA, J. P, MERROUCHE, Y, LE BAIL, N, ALAKL, M. K, DUMORTIER, A, FOY, M, CLAVEL, M
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Asthenia - chemically induced
Biological and medical sciences
Chemotherapy
Dose-Response Relationship, Drug
Female
Humans
Hypotension - chemically induced
Imidazoles - administration & dosage
Imidazoles - adverse effects
Imidazoles - therapeutic use
Infusions, Intravenous
Male
Medical sciences
Middle Aged
Nausea - chemically induced
Neoplasms - drug therapy
Pharmacology. Drug treatments
Propanolamines - administration & dosage
Propanolamines - adverse effects
Propanolamines - therapeutic use
Protein Synthesis Inhibitors - administration & dosage
Protein Synthesis Inhibitors - adverse effects
Protein Synthesis Inhibitors - therapeutic use
Vomiting - chemically induced
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Summary:Giroline (RP 49532A) is a new protein-synthesis inhibitor with broad antitumor activity in experimental models. In the present phase I study, Giroline was given by 24-h i.v. infusion every 3 weeks at doses ranging from 3 to 15 mg/m2 to 12 patients with advanced refractory solid tumors. The dose-limiting toxic effects were delayed hypotension and severe asthenia. The maximum tolerated dose (MTD) was 15 mg/m2. Transient nausea and vomiting during infusion were reported at all dose levels. Mild reversible prolongation of prothrombin time and activated partial thromboplastin time was observed in most patients at dose levels above 3 mg/m2. No antitumor activity was observed. The toxicity profile of Giroline precludes further evaluation in cancer patients.
ISSN:0344-5704
1432-0843
DOI:10.1007/BF00686555