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

NCT00861328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-06-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ON 01910.Na and irinotecan

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.

DRUG

ON 01910.Na and 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 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.

Sponsors & Collaborators

  • Traws Pharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Sridhar Mani, MD · Albert Einstein College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861328 on ClinicalTrials.gov