Experiment 915302
Worktypes
Compounds isolated
Details
| Property | Value |
|---|---|
| Pharmacology | |
| Administration route | IP |
| Organism | Empty organism |
| Citation | CANAL,P: BUGAT,R: CHATELUT,E: PINEL,MC: HOUIN,G: PLUSQUELLEC,Y: CARTON,M:. (1989). PHASE I/PHARMACOKINETIC STUDY OF INTRAPERITONEAL TENIPOSIDE (VM 26).. 25(5) |
| Amount utilized | |
| Compound isolated | |
| Disease | A PHASE I/PHARMACOKINETIC STUDY OF TENIPOSIDE WAS REPORTED. 18 PATIENTS WITH VARIOUS MALIGNANCIES AND REFRACTORY MALIGNANT ASCITES WERE IN THE STUDY. THE DOSE ESCALATION WAS MADE ACCORDING TO THE MODIFIED FIBONACCI SCHEME. 24 COURSES WERE EVALUABLE FOR TOXICITY, RESPONSE AND PHARMACOKINETICS. THE MAXIMUM TOLERATED DOSE WAS REACHED AT 45 MCG/SQ M AND THE LIMITING TOXICITY WAS MYELOSUPPRESSION, PRINCIPALLY LEUKOPENIA. ABDOMINAL PAIN OCCURRED IN 1/2 OF THE COURSES BUT WAS NOT LIMITING. NO PARTIAL REMISSION, BUT 2 "NO CHANGE" WERE ACHIEVED FOR MORE THAN 2 MONTHS. A REDUCTION OR DISAPPEARANCE OF ASCITES WAS SEEN IN 2 PATIENTS. PHARMACOKINETIC STUDIES, CARRIED OUT IN ALL COURSES, SHOWED THAT THE TOTAL EXPOSURE FOR PERITONEAL CAVITY AVERAGED 10-FOLD GREATER THAN THAT OF PLASMA. BASED ON THE OUTCOME OF THIS PHASE I STUDY, IT IS RECOMMENDED THAT PHASE II STUDIES AT A DOSE OF 390 MG/SQ M I.P. REPEATED EVERY 4 WEEKS WITH A 4 HOUR DWELL TIME BE CONDUCTED. |
| Dose amount | 450.0 MG |
| Number | 2 |
| Qualitative result | ACTIVE |
| Animal | HUMAN ADULT |
| Per unit | SQ M BODY SURFACE |
| Dose expression | DOSE |
| Gender | GIVEN TO BOTH SEXES |