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Sponsored by: |
Onconova Therapeutics, Inc. |
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Information provided by: | Onconova Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00861783 |
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.
Condition | Intervention | Phase |
---|---|---|
Hepatoma Advanced Solid Tumor |
Drug: irinotecan and ON 01910.Na Drug: oxaliplatin and ON 01910.Na |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 18 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A - irinotecan: Experimental
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. |
Drug: 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. 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. |
Group B - oxaliplatin: Experimental
Treatment with escalating doses of ON 01910.Na in combination with oxaliplatin.
|
Drug: oxaliplatin 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. |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Francois E. Wilhelm, MD, PhD | 267 759-3680 | fwilhelm@onconova.us |
United States, New York | |
Mount Sinai Medical Center | Recruiting |
New York, New York, United States, 10029 | |
Principal Investigator: Takao Ohnuma, MD, PhD |
Responsible Party: | Onconova Therapeutics, Inc. ( Francois E. Wilhelm, MD, PhD, Chief Medical Officer ) |
Study ID Numbers: | Onconova 04-08 |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861783 History of Changes |
Health Authority: | United States: Food and Drug Administration |
oxaliplatin diaminocyclohexane oxalatoplatinum oxalatoplatin oxalatoplatinum Eloxatin |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Irinotecan Camptothecin Carcinoma Liver Neoplasms |
Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |
Liver Diseases Digestive System Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Carcinoma, Hepatocellular Irinotecan Enzyme Inhibitors Pharmacologic Actions Carcinoma |
Liver Neoplasms Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial |