Advanced Cancer Clinical Trial
Official title:
A Phase I, Multi-Center, Dose-Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of AV-412 Administered Orally Three Times Weekly to Subjects With Advanced Solid Tumors
The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of
cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for
treatment of various solid tumors. AV-412 is a novel inhibitor of the EGFR-tyrosine kinase,
with added activity against Her2 and other oncogenic kinases. Based on evidence of
preclinical activity in various solid tumors, AV-412 is being developed as a possible novel
treatment for cancer in humans.
PURPOSE: The purpose of this study is to test the safety and tolerability of AV-412, and
determine the maximum tolerated dose of AV-412 when administered orally three times weekly.
This is an open-label, dose escalation trial, and all subjects will receive oral AV-412
administered three times weekly or once weekly for 4 weeks (1 cycle) to evaluate safety and
tolerability of AV-412. Treatment duration will be a minimum of 2 consecutive dosing cycles
(8 weeks), if tolerated.
- Upon completion of the 2 cycles, subjects with documented stable disease or an
objective response may continue to receive therapy at the same dose and schedule
previously utilized, as long as tolerability is acceptable, for up to 1 year. Treatment
beyond 1 year from the time of enrollment will be reviewed on a case-by-case basis
between the sponsor and investigator.
- Subjects experiencing unacceptable toxicities or with documented disease progression
will be discontinued from further participation in the study Accrual to next cohort
will occur only after acceptable tolerance has been demonstrated throughout Cycle 1,
and only after consultation with medical monitor.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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