A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, PK, and PD Study of CNF2024 Administered Orally Twice Weekly for 3 Weeks of a 4 Week Course or Twice Weekly for 4 Weeks of a 4 Week Course to Patients With Advanced Solid Tumors
Heat shock protein 90 (Hsp90) is an ubiquitous molecular chaperone protein that is involved
in folding, activation, and assembly of many proteins, including key mediators of signal
transduction, cell cycle control, and transcriptional regulation. In cancer cells that are
dependent upon Hsp90 client proteins, the degree to which clients are inhibited correlates
closely with induction of growth inhibition and apoptosis with Hsp90 inhibitory drugs. The
active pharmaceutical ingredient of CNF2024, CF1983 mesylate, is a synthetic, new chemical
entity designed to inhibit Hsp90. CF1983 hada strong affinity for tumor derived Hsp90 and
weaker affinity for Hsp90 isolated from normal cells or recombinant Hsp90.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose (MTD)
Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment.
Yes
Biogen Idec Medical Monitor, MD
Study Director
Biogen Idec
United States: Food and Drug Administration
CNF2024-ST-05003
NCT00345189
February 2006
April 2009
Name | Location |
---|---|
Research Site | Mesa, Arizona |
Research Site | Danbury, Connecticut |
Research Site | Abilene, Texas |