Safety Study of ON 01910.Na in Combination With Irinotecan or Oxaliplatin

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

Sponsor
Traws Pharma, Inc.
Study ID
NCT00861328
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • ON 01910.Na and irinotecan — 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 dose levels after safety evaluation. The suggested starting dose of Irinotecan is 180 mg/m2 administered by intravenous (IV) infusion over 90 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Reductions in the starting doses according to recommendations of current approved prescribing information may be considered after review of patients' medical histories and potential tolerances to treatment with the chemotherapy agent.
  • ON 01910.Na and oxaliplatin — 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 dose levels after safety review of the combination regimen in the previous cohort. The suggested starting dose of Oxaliplatin is 85 mg/m2 administered by IV infusion over 120 minutes every 2 weeks of a 6-week cycle (3 doses per cycle). Reductions in the starting doses according to recommendations of current approved prescribing information may be considered after review of patients' medical histories and potential tolerances to treatment with the chemotherapy agent.

Study Details

Treatment of cancer is often improved if two or more drugs are used in combination. In animal studies, the use of the combination of ON 01910.Na (a new, unapproved drug) and irinotecan or oxaliplatin (two approved and extensively used anti-cancer drugs) gave better results against tumor cells than the use of any of the single drugs alone. In addition, the use of the combinations did not result in an increase of side effects. This clinical trial will determine what is the highest dose of ON 01910.Na that can be given safely in combination with either irinotecan or oxaliplatin in human patients.

Key Dates

Start date
Feb 29, 2008
Status verified
Jun 2017
Primary completion
Jul 31, 2011
Completion
Jul 31, 2011

Study Design

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

Arms

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

Primary Outcome Measure

maximum tolerated dose [ Time Frame: 1 - 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Albert Einstein Cancer CenterThe BronxNew York10461-

Find similar trials in The Bronx, NY

By research site
Albert Einstein Cancer Center· The Bronx, NY

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