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

Part of paid clinical trials in New York, New York.

Sponsor
Traws Pharma, Inc.
Study ID
NCT00861783
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor
  • Hepatoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • irinotecan and ON 01910.Na — DRUG
    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.
  • oxaliplatin and ON 01910.Na — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2008
Status verified
Jun 2017
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Group A - irinotecan
    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.
  • Experimental: Group B - oxaliplatin
    Treatment with escalating doses of ON 01910.Na in combination with oxaliplatin.

Primary Outcome Measure

maximum tolerated dose [ Time Frame: 6 - 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Medical CenterNew YorkNew York10029-

Find similar trials in New York, NY

By research site
Mount Sinai Medical Center· New York, NY

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