Neoplasms

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Carcinoma, Hepatocellular

Liver Neoplasms

Carcinoma

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

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Amino Acids

Oxaliplatin

Irinotecan

Camptothecin

ON 01910

Glycine

Topoisomerase I Inhibitors

Enzyme Inhibitors

Protein Kinase Inhibitors

Neurotransmitter Agents

Note: As of Amendment 2 (March 2009), treatment in the irinotecan arm of the study (Group A) is closed to enrollment.

Treatment with escalating doses of ON 01910.Na in combination with irinotecan.

Treatment with escalating doses of ON 01910.Na in combination with oxaliplatin.

ON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher levels based on safety of the combination regimen in the previous cohort.

Irinotecan 180 mg/m2 will initially be administered by IV infusion over 90 minutes q2 weeks of a 6-week cycle (3 doses per cycle). Dose modifications due to toxicity will be instituted according to approved labelling.

irinotecan and ON 01910.Na

ON 01910.Na will be administered by IV infusion over 24 hours once per week in a 6-week cycle (6 doses per cycle). The dose of ON 01910.Na will start at 250 mg/m2 and will proceed to higher levels based on safety of the combination regimen in the previous cohort.

Oxaliplatin 85 mg/m2 will initially be administered by IV infusion over 120 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Dose modifications due to toxicity will be instituted according to approved labeling.

oxaliplatin and ON 01910.Na

Takao Ohnuma, M.D.

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.

Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma

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

Traws Pharma, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma	NCT00861783	Hepatoma Advanced Solid ...	irinotecan and ... oxaliplatin and...	18 Years -	Traws Pharma, Inc.
Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma	NCT00861783	Hepatoma Advanced Solid ...	irinotecan and ... oxaliplatin and...	18 Years -	Traws Pharma, Inc.

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