Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Lymphoid Malignancies

Thank you

Trial Information

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


RTA 402 is a synthetic triterpenoid that has demonstrated significant in vivo single agent
anti-cancer activity. This is an open-label phase I dose-escalation study of RTA 402
administered orally for the first 21 days of a 28-day cycle.


Inclusion Criteria:



- 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
therapies exist.

- 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
g/dl.

- 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
ingested.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 Capsules

Authority:

United States: Food and Drug Administration

Study ID:

402-C-0501

NCT ID:

NCT00529438

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Advanced Solid Tumors
  • Lymphoid Malignancies
  • Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Case Western Reserve UniversityCleveland, Ohio  44106