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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

Phase 1
18 Years
Not Enrolling
Advanced Solid Tumors

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Trial Information

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

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.

Inclusion Criteria:

- Male and female patients ≥18 years of age with histologically or cytologically
confirmed 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 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.

- UGT1A1 genotype of patient must be known or a UGT1A1 genotype test must be done for
patients being considered for treatment in Group A.

Exclusion Criteria:

- 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 varices have been
sclerosed or banded and bleeding episodes have not occurred during the prior 6

- 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 who are homozygous for the UGT1A1*28 allele will be excluded from
participating in Group A of this protocol.

- Patients with ascites requiring active medical management including paracentesis,
peripheral bilateral edema or hyponatremia (defined as serum sodium value of <134

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

1 - 3 months

Safety Issue:


Principal Investigator

Sridhar Mani, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Albert Einstein College of Medicine of Yeshiva University


United States: Food and Drug Administration

Study ID:

Onconova 04-06



Start Date:

February 2008

Completion Date:

July 2011

Related Keywords:

  • Advanced Solid Tumors
  • Phase 1
  • maximum tolerated dose
  • oxaliplatin
  • irinotecan
  • ON 01910.Na



Albert Einstein Cancer Center Bronx, New York  10461