A Phase I Dose-Finding and Pharmacokinetic Study of RTA 402 (CDDOMe) Administered Orally for 21 Days of a 28-Day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies
- Histopathological documentation of solid tumor or lymphoid malignancy.
- Advanced or metastatic cancer that is either refractory to or have relapsed after
standard-of-care curative or survival-prolonging therapy, or for whom no such
- ECOG performance status of less than or equal to 2
- Adequate liver and renal function as documented by the following laboratory test
results within 14 days of starting therapy: total bilirubin ≤ 1.5 mg/dL; AST (SGOT)
and ALT(SGPT) ≤ 2.5 ULN or ≤ 5 ULN if liver is involved by tumor; serum creatinine
≤2.0 mg/dL OR creatinine clearance >60 mL/min.
- Adequate bone marrow function as documented by the following laboratory test results
within 14 days of starting therapy: platelets greater than 100,000/mm3, absolute
granulocyte count greater than 1,500/mm3, hemoglobin greater than or equal to 8.0
- Completion of prior chemotherapy, hormonal therapy, radiation therapy, biological
therapy, or other investigational cancer therapy, for at least 4 weeks prior to study
entry and must have recovered from all acute side effects (to CTC grade 1 or less)
prior to initiation of RTA 402. Patients who were receiving mitomycin C or
nitrosoureas must be 6 weeks from the last administration of chemotherapy.
- Agree to practice effective contraception during the entire study period.
- Life expectancy of more than 3 months
- Able and willing to sign the informed consent form.
- Willing and able to self-administer orally and document all doses of RTA 402
- Active brain metastases or primary CNS malignancies.
- Pregnant or breast feeding
- Clinically significant illnesses including, but not limited to: Uncontrolled
diabetes; Active or uncontrolled infection; Acute or chronic liver disease; Confirmed
diagnosis of HIV infection; Uncontrolled hypertension, symptomatic congestive heart
failure, unstable angina pectoris, myocardial infarction within the past 6 months, or
uncontrolled cardiac arrhythmia.
- Psychiatric illness that would limit compliance with study requirements.