A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral CGM097, a p53/HDM2-interaction Inhibitor, in Adult Patients With Selected Advanced Solid Tumors
This is a multi-center, open-label, dose finding, phase I study of single agent CGM097,
administered in patients with advanced solid tumors who have progressed despite standard
therapy or for whom no standard therapy exists. Patients' tumors must be characterized by
p53wt status.
The study consists of a dose escalation part, where cohorts of three to six newly enrolled
patients will receive escalating doses of CGM097, and a dose expansion part, in which
patients are given CGM097 the maximum tolerated dose (MTD) or Recommended Phase 2 Dose
(RP2D). Novartis and the site investigators will jointly decide on each dose escalation step
based on the recommendation from an adaptive Bayesian logistic regression model (BLRM). If
safety data should indicate a lower increment than suggested by the BLRM, the next dose
level (DL) will be adjusted accordingly.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Dose Limiting Toxicities
To characterize the maximum tolerated dose (MTD) and/or identify the recommended dose for expansion(RDE) of CGM097. Dose Limiting Toxicities will be listed and their incidence summarized by primary system organ class, worst grade based on CTCAE version 4.03 and type of Adverse Event
From day 1 to day 28 of treatment
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CCGM097X2101
NCT01760525
March 2013
June 2016
Name | Location |
---|---|
Dana Farber Cancer Institute SC (2) | Boston, Massachusetts 02115 |