RTA 402 in Advanced Solid Tumors or Lymphoid Malignancies

NCT00508807 | Completed Phase 1

• 1 other identifier: 2005-0984
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoid Malignancies; Solid Tumors

Keywords

Lymphoid Malignancies; Solid Tumors; RTA 402

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of RTA 402

  28 day cycles

Study Arms (1)

RTA 402

EXPERIMENTAL

5 mg PO daily x 21 days

Drug: RTA 402

Interventions

RTA 402 DRUG

5 mg by mouth (PO) daily for 21 days

RTA 402

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>/= 18 years
• Patient must have histopathological documentation of solid tumor or lymphoid malignancy. (measurable disease is not required)
• 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)
• Patient must be ECOG performance status of less than or equal to 2.
• 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
• 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.
• 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.
• Patient (man or woman) must agree to practice effective contraception during the entire study period unless documentation of infertility exists.

You may not qualify if:

• Patients with active brain metastases or primary CNS malignancies. (patients with a previously treated brain metastasis may be included)
• Patients who are pregnant or breast feeding
• 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.
• Patients with psychiatric illness that would limit compliance with study requirements

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Reata Pharmaceuticals, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center website

Study Officials

• David S. Hong, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 30, 2007
• Study Start: April 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)