NCT00861328

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

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 Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Traws Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label, 2-arm, dose-escalation combination-therapy study in which patients with 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). The Investigator will make this assignment using clinical judgment, taking into consideration the patient's tumor type, UGT1A1 genotype when applicable (i.e., patients considered for treatment in Group A will be tested for UGT1A1 genotype, if not already known, and patients homozygous for the UGT1A1\*28 allele will be excluded from Group A), prior treatment, and current clinical condition. Patients will be enrolled in 1 of 8 Cohorts (4 sequential Cohorts in Group A and 4 in Group B) of 3 patients each. Up to 6 additional patients will be tested at the MTD. Groups A and B will enroll and proceed simultaneously.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-03-13
• Last updated: 2017-06-23

Locations

1 site across 1 country: United States