Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
Summary
Studies done in the laboratory have demonstrated beneficial effects of ON 01910.Na, a new,
unapproved drug, when it is used in combination either irinotecan and oxaliplatin, two
approved, extensively used anti-cancer drugs. In these laboratory studies, mice implanted
with cells (Bel-7402 cells) that came from a human tumor were used as a model of liver
cancer. In mice that were not treated, the Bel-7402 cells formed very large tumors. In mice
that were treated with ON 01910.Na, irinotecan or oxaliplatin alone, growth of tumors was
reduced compared to the untreated group. When a combination of ON 01910.Na and irinotecan or
of ON 01910.Na and oxaliplatin was used to treat the mice, tumor growth was completely
inhibited. Another observation in these studies was that toxicity did not increase when the
combinations were used. These results and similar results from other studies support the
hypothesis that a combination of ON 01910.Na and irinotecan or of ON 01910.Na and oxaliplatin
would be an effective and tolerable treatment for liver and other types of cancer.
The primary objective of this phase 1 study is to find out what doses of ON 01910.Na in
combination with either irinotecan or oxaliplatin are safe and tolerable in patients with
liver and other types of cancer.
Phase:
Phase 1
Details
Lead Sponsor:
Onconova Therapeutics, Inc.
Treatments:
Camptothecin Glycine Irinotecan ON 01910 Oxaliplatin