RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies

This study has been completed.
Sponsor:
Collaborator:
Reata Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508807
First received: July 26, 2007
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

Primary:

  • To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of RTA 402 capsules in patients with advanced solid tumors or lymphoid malignancies who have failed standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist.
  • To characterize the pharmacokinetics of RTA 402 capsules administered orally for 21 days in this patient population.

Secondary:

  • To document any preliminary antitumor activity of RTA 402 in this patient population.
  • To determine the in vivo molecular and biological effects of RTA 402 by measuring changes in markers of differentiation, apoptosis, and anti-inflammatory effects in WBCs, blood plasma, and, in consenting patients, tumor biopsies.
  • To correlate the biological activity of RTA 402 with drug concentration in plasma and blood cellular elements
  • To evaluate the series of inflammation related symptoms over the course of the study, and to determine the correlation of symptom intensity with plasma cytokines.

Condition Intervention Phase
Lymphoid Malignancies
Solid Tumors
Drug: RTA 402
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study Protocol RTA 402-C-0501: A Phase I Dose-finding and Pharmacokinetic Study of RTA 402 (CDDO-Me) Administered Orally for 21 Days of a 28-day Cycle in Patients With Advanced Solid Tumors or Lymphoid Malignancies

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose of RTA 402 [ Time Frame: 28 day cycles ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RTA 402
5 mg PO daily x 21 days
Drug: RTA 402
5 mg by mouth (PO) daily for 21 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Age >/= 18 years
  2. Patient must have histopathological documentation of solid tumor or lymphoid malignancy. (measurable disease is not required)
  3. Patient must have advanced or metastatic cancer that are either refractory or has relapsed after standard-of-care curative or survival-prolonging therapy, or for whom no such therapies exist. (there is no limit on the number of prior lines of therapy)
  4. Patient must be ECOG performance status of less than or equal to 2.
  5. Patient must have 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
    • creatinine </= 2.0 mg/dL OR creatinine clearance > 60 mL/min
  6. Patient must have adequate bone marrow function as documented by the following laboratory test results within 14 days of starting therapy:

    • platelets greater than 100,000/mm^3,
    • absolute granulocyte count greater than 1,500/mm^3,
    • hemoglobin greater than or equal to 8.0 g/dl.
  7. Patient must have completed prior chemotherapy, hormonal therapy, radiation therapy, biological therapy, or other investigational cancer therapy at least 4 weeks prior to starting RTA 402, 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.
  8. Patient (man or woman) must agree to practice effective contraception during the entire study period unless documentation of infertility exists.
  9. Patient must have a life expectancy of more than 3 months.
  10. Patient must be able and willing to sign the informed consent form.
  11. Patient must be willing and able to self-administer orally and document all doses of RTA 402 ingested.

Exclusion:

  1. Patients with active brain metastases or primary CNS malignancies. (patients with a previously treated brain metastasis may be included)
  2. Patients who are pregnant or breast feeding
  3. Patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to:

    • uncontrolled diabetes
    • active or uncontrolled infection
    • acute or chronic liver disease (i.e., hepatitis, cirrhosis)
    • 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.
  4. Patients with psychiatric illness that would limit compliance with study requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508807

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Reata Pharmaceuticals, Inc.
Investigators
Principal Investigator: David S. Hong, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508807     History of Changes
Other Study ID Numbers: 2005-0984
Study First Received: July 26, 2007
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Lymphoid Malignancies
Solid Tumors
RTA 402

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014