Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
The question being asked in this study is: Will patients with advanced pancreatic cancer live
significantly longer if they are treated with a combination of Gemcitabine and ON 01910.Na
than if they are treated with Gemcitabine alone? There are two parts to this study. In the
first part of the study, patients with metastatic pancreatic cancer who have received no
prior chemotherapy for this disease will be assigned by chance either to the group that will
be treated with both Gemcitabine and ON 01910.Na (about 100 patients will be in this group)
or, to the group that will be treated with Gemcitabine only (about 50 patients will be in
this group). How long patients survive in the 2 groups will be compared. If it looks like
there is no difference between the groups, the study will stop. If it looks like patients in
the group that were treated with both Gemcitabine and ON 01910.Na survive longer, the study
will continue into a second part where more patients will be treated in order to confirm and
better understand the findings of the first part of the study.
Phase:
Phase 3
Details
Lead Sponsor:
Onconova Therapeutics, Inc.
Collaborators:
Academic GI Cancer Consortium (AGICC) Academic Oncology Gastrointestinal Cancer Consortium (AGICC)