Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1 Dose-Escalation Study of the Safety and Clinical Effects of ON 01910.Na in Combination With Either Irinotecan or Oxaliplatin in Patients With Hepatoma and Other Advanced Solid Tumors
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.
This is an open-label, 2-arm, dose-escalation combination-therapy study in which patients with hepatoma and other advanced malignancies will be assigned by the Investigator to dosing with either irinotecan plus ON 01910.Na (Group A), or oxaliplatin plus ON 01910.Na (Group B). Note: As of Amendment 2 of this protocol, treatment in the irinotecan arm of the study (Group A) is closed to enrollment and patients will be enrolled only in Group B, the oxaliplatin treatment arm. Patients will be enrolled in 1 of 4 Cohorts (4 sequential Cohorts in Group B) of 3 patients each. Up to 6 additional patients will be tested at the MTD. ;
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