Protocol I6F-MC-JJCA: A Phase 1 Study of LY3039478 in Patients with Advanced or Metastatic Cancer

Protocol: 
AAAQ7203
Phase: 
I

Protocol I6F-MC-JJCA: A Phase 1 Study of LY3039478 in Patients with Advanced or Metastatic Cancer

ProNAi Therapeutics, Inc. has developed a new type of investigational drug called PNT2258 that may be effective in blocking the “on” signal to cancer cells, eventually causing them to die. The study drug (PNT2258) is undergoing evaluation and has not been approved for sale by the United States Food and Drug Administration (FDA), Health Canada (HC), European Medicines Agency (EMA) or any other regulatory agencies. Study patients enrolled in this study all have tumors that are influenced by the BCL-2 protein. The sponsor is trying to see if PNT2258 provides evidence of anti-tumor effect by measuring what happens to tumors after exposure to PNT2258. Specifically, the sponsor is looking to see if the tumors shrink (evaluated by computed tomography, also known as a “CT scan”) or have decreased activity (evaluated by positron emission tomography, also known as a “PET scan”). If this is the case, PNT2258 will continue along in its clinical development and might eventually be used in a much larger group of study patients, but this will not occur until there is more efficacy (effectiveness) and safety information from this study.

Are you Eligible? (Inclusion Criteria)

Inclusion:
- The patient must have histologically confirmed diagnosis of diffuse large
B-cell lymphoma
according to World Health Organization criteria for diagnosis of NHL in the
setting of Richter's
transformation (RT) from chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL)
- Evidence of progressive disease during or following the last therapeutic
regimen for CLL/SLL or RT, or evidence of transformation during or following
the last therapeutic regimen for CLL/SLL.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States