Status:
COMPLETED
Safety of ON 01910.Na and Irinotecan or ON 01910.Na and Oxaliplatin in Patients With Hepatoma
Lead Sponsor:
Traws Pharma, Inc.
Conditions:
Hepatoma
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 irino...
Eligibility Criteria
Inclusion
- Male and female patients ≥18 years of age with histologically or cytologically confirmed hepatoma and other solid tumors that are metastatic or progressive, for whom no standard therapy holds curative potential and for whom irinotecan or oxaliplatin are reasonable treatment options.
- Patients must have evaluable disease, either measurable on imaging or with informative tumor marker(s).
- Eastern Collaborative Oncology Group (ECOG) Performance Status of ≤2.
- Life expectancy \>12 weeks.
- Any acute or chronic adverse effects of prior chemotherapy have resolved to \<Grade 2 as determined by CTCAE v3 criteria.
- Existing or planned central venous access with a 2-channel infusion catheter system.
- Laboratory values meet the following criteria: Absolute neutrophil count ≥1,500 cells/µL; Platelets ≥100,000 cells/µL; Total bilirubin ≤1.5 times the upper limit of normal; AST (SGOT) ≤2.5 times the upper limit of normal; ALT (SGPT) ≤2.5 times the upper limit of normal; Serum creatinine ≤1.5 mg/dL or a measured creatinine clearance ≥50 mL/min; Negative βhCG test in women of childbearing potential (defined as women ≤50 years of age or history of amenorrhea for ≤12 months prior to study entry).
- Patients with primary liver cancer or hepatic metastasis are eligible to enroll, provided they meet the following: Total bilirubin is ≤2 mg/dL; AST and ALT are each ≤5 times the institutional upper limit of normal; Ascites, if present, is manageable with diuretic agents alone.
- If there is a history of treated brain metastases, these must have been clinically stable for ≥4 weeks prior to enrollment.
Exclusion
- Women who are pregnant or lactating.
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Severe liver dysfunction (Child-Pugh Class C or uncompensated Class B with persistent encephalopathy, persistent ascites, or prothrombin time \>1.5 times the upper limit of normal) is present.
- Patients with a history of esophageal bleeding are excluded unless arices have been sclerosed or banded and bleeding episodes have not occurred during the prior 6 months.
- Contraindications, including known hypersensitivity, to the assigned chemotherapy agent (i.e., irinotecan or oxaliplatin).
- Prior receipt of ON 01910.Na or prior participation in this protocol.
- Use of any investigational agents within 4 weeks of study enrollment.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the Investigator.
- Patients with ascites requiring active medical management including paracentesis, peripheral bilateral edema or hyponatremia (defined as serum sodium value of \<134 Meq/L).
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00861783
Start Date
June 1 2008
End Date
July 1 2011
Last Update
June 23 2017
Active Locations (1)
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1
Mount Sinai Medical Center
New York, New York, United States, 10029