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Trial record 1 of 1 for:    NCT00538343
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RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00538343
Recruitment Status : Terminated (Business Decision)
First Posted : October 2, 2007
Last Update Posted : November 26, 2014
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to determine whether RTA 744 is effective in the treatment of breast cancer that has metastasized to the brain.

Condition or disease Intervention/treatment Phase
Brain Metastases Drug: berubicin hydrochloride (RTA 744) Phase 2

Detailed Description:
RTA 744 is a novel, anthracycline that has shown the ability to circumvent ATP-binding cassette transporters (Multidrug Resistance Protein 1, Breast Cancer Resistance Protein, P-glycoprotein) in vitro. This action enables RTA 744 to penetrate across the blood brain barrier. In a Phase I safety study, RTA 744 was shown to be generally well tolerated in patients with recurrent glioblastoma multiforme (GBM). Additionally, anti-tumor activity was observed. Breast cancer is known to be sensitive to anthracycline therapy. Based on the preliminary Phase I clinical results and the sensitivity of breast cancer to anthracycline therapy, this Phase II study will investigate the safety and efficacy of RTA 744 in patients with breast cancer and metastatic disease to the brain which has progressed following whole brain irradiation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Efficacy and Tolerability Study of RTA 744 in Breast Cancer Patients With Progression of Previously Irradiated Brain Metastases
Study Start Date : October 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: RTA 744 Drug: berubicin hydrochloride (RTA 744)

Primary Outcome Measures :
  1. To evaluate the efficacy of RTA 744 in reducing intracranial tumor on contrast-enhanced MRI of breast cancer patients with progression of brain metastases following whole brain radiotherapy (WBRT). [ Time Frame: 21 Days ]

Secondary Outcome Measures :
  1. To evaluate the efficacy of RTA 744 on intracranial tumor as measured by intracranial objective response rate (Intracranial ORR) determined by modified RECIST criteria and by volumetric analysis. [ Time Frame: 18 weeks ]
  2. To evaluate overall objective response rate after administration of RTA 744. [ Time Frame: 18 weeks ]
  3. To evaluate the efficacy of RTA 744 on intracranial tumor as measured by intracranial Time To Progression. [ Time Frame: 18 weeks ]
  4. To evaluate progression free survival (PFS) after administration of RTA 744. [ Time Frame: 18 weeks ]
  5. To evaluate overall survival (OS) after administration of RTA 744. [ Time Frame: 18 weeks ]
  6. To evaluate the safety and tolerability of RTA 744 administered at 7.5 mg/m2/day for 3 consecutive days on a 21-day cycle. [ Time Frame: 18 weeks ]
  7. To evaluate the impact of RTA 744 on quality of life through the FACT-B and modified FACT-Br questionnaires. [ Time Frame: 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically-confirmed adenocarcinoma of the breast with at least one evaluable brain lesion ( ≥ 1 cm in one dimension) on contrast-enhanced MRI after WBRT and documented intracranial failure/progression i. Presence of any new lesion(s); or ii. ≥ 25% increase in bi-dimensional measurement of existing tumor
  2. Definitive radiotherapy ≥ 3000 cGy for documented CNS disease completed ≥ 4 weeks prior to initiation of protocol therapy
  3. ≥ 2 weeks since stereotactic radiosurgery or gamma knife therapy
  4. ≥ 4 weeks since neurosurgery (open brain or stereotactic brain biopsy). Patients must have completely recovered from the side effects of surgical procedure.
  5. ≥ 2 weeks since major surgery (other than neurosurgical procedure) and complete recovery from this surgical procedure.
  6. Most recent chemotherapeutic treatment regimen completed ≥ 2 weeks prior to study entry provided toxicities have resolved.

    i. Hormone receptor positive patients must have progressed on one prior hormonal AND at least one prior chemotherapy course in the metastatic setting.

    ii. Hormone receptor negative patients must have progressed on at least one prior chemotherapy course in the metastatic setting.

    iii. Her2 positive patients must have progressed on at least one prior chemotherapeutic and one Her2-targeted combination course in the metastatic setting.

  7. Life expectancy ≥ 12 weeks.
  8. Patients receiving corticosteroids must have been on a stable dose for 2 weeks prior to study enrollment.
  9. LVEF ≥ 50% on MUGA or ECHO
  10. ECOG performance status of 0-2.
  11. Laboratory values confirmed within 14 days of initiation of study therapy: Granulocytes ≥ 1,500/μL; Lymphocytes ≥ 1,000/μL; Platelets ≥ 100,000/μL; Hemoglobin ≥ 9 gm/dL; Total Bilirubin < 1.5 times upper limit of normal (ULN); ALT and AST < 1.5 times ULN (< 5 times ULN in patients with liver metastases); Creatinine < 1.5 times ULN
  12. Women of childbearing potential must have negative serum pregnancy test, and must agree to use adequate contraceptive method during administration of study treatment and for three months after completing treatment.
  13. Cognitive ability to provide written informed consent and comply with study requirements including follow-up procedures.

Exclusion Criteria:

  1. Evidence of new or progressive metastatic disease in the brainstem or intramedullary upper spinal cord. (Metastases in the thalamus are allowed).
  2. Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology. (Discrete dural metastases are permitted.)
  3. Evidence of impending herniation on baseline MRI.
  4. Evidence of CNS hemorrhage on baseline MRI (within 14 days of study enrollment).
  5. Grade 3 or 4 motor, sensory, or cranial neuropathy symptoms; Grade 3 or 4 seizures, headache or nausea/vomiting.
  6. Evidence of bleeding diathesis, coagulopathy or requirement for therapeutic anticoagulation.
  7. Total lifetime, cumulative anthracycline dose > 350 mg/m2.
  8. Impaired cardiac function or other significant cardiac disease or arrhythmia of any type including: Complete left bundle branch block; Severe aortic stenosis iii. Obligate use of a cardiac pacemaker; ST depression of > 1mm in ≥ 2 leads and/or T wave inversions in ≥ 2 contiguous leads; Congenital long QT syndrome; History or presence of ventricular or atrial arrhythmia; Clinically significant bradycardia; QTc > 480 msec on EKG; Uncontrolled hypertension, history of labile hypertension or history of poor compliance with anti-hypertensive regimen; New York Heart Association (NYHA) Grade II or greater congestive heart failure (CHF); History of myocardial infarction within the past 6 months within the past 6 months
  9. Concurrent or recent (within 4 weeks prior to randomization) medication(s) that may interfere with study treatment or results, i.e., immunosuppressants other than corticosteroids, enzyme-inducing anti-epileptics and agents that prolong the QTc.
  10. Concurrent or planned hormonal, chemotherapeutic, experimental, or targeted biologic therapy.
  11. Any of the following concurrent severe or uncontrolled medical condition which could compromise participation in the study: Uncontrolled diabetes; Active or uncontrolled infection; Acute or chronic liver disease (i.e. hepatitis, cirrhosis); Patients having a contraindication to MRI imaging
  12. Pregnant
  13. Inability to comply with study and/or follow-up procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00538343

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United States, Florida
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, North Carolina
Presbyterian Health Care
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 25184
Moses Cone Regional Cancer Center
Greensboro, North Carolina, United States, 27403
Forsyth Regional Cancer Center
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Texas Oncology, PA
Dallas, Texas, United States, 75246
United States, Virginia
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
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Responsible Party: Reata Pharmaceuticals, Inc. Identifier: NCT00538343    
Other Study ID Numbers: RTA 744-C-0703
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014
Keywords provided by Reata Pharmaceuticals, Inc.:
brain metastases
breast cancer
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases