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Trial record 1 of 1 for:    NCT00828854
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A Phase 2, Multicenter Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing

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: NCT00828854
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : February 3, 2010
Information provided by:
Syndax Pharmaceuticals

Brief Summary:

The addition of SNDX-275 to an AI will result in a maximal abrogation of estrogen receptor-α mediated activity and inhibit mechanisms of resistance to the aromatase inhibitor.

It is hypothesized that SNDX-275 with continued AI will increase the estimated AI clinical benefit rate (CBR) from 5% to 25% with an acceptable safety profile.

Condition or disease Intervention/treatment Phase
ER+ Breast Cancer Drug: entinostat (SNDX-275) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter Study of the Effect of the Addition of SNDX-275 to Continued Aromatase Inhibitor (AI) Therapy in Postmenopausal Women With ER+ Breast Cancer Whose Disease is Progressing
Study Start Date : April 2008
Actual Primary Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: treatment
Continued treatment with same AI at labeled dose and schedule, plus Entinostat (5mg PO every week)
Drug: entinostat (SNDX-275)
5 mg PO every week

Primary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Progression free survival (PFS)
  2. Objective response rate (ORR) during the first 6 cycles of study treatment [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Postmenopausal female patients.
  2. Histologically or cytologically confirmed ER+ breast cancer.
  3. Progressive disease (PD) after at least 3 months on treatment with a 3rd generation AI in the advanced disease setting as measured by RECIST criteria.
  4. At least 1 measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan with the last imaging performed within 4 weeks prior to study entry. If there is only one measurable lesion and it is located in previously irradiated field, it must have demonstrated progression according to RECIST criteria.
  5. ECOG 0-1.
  6. Laboratory parameters:

    1. Hemoglobin ≥ 9.0 g/dL; platelets ≥ 100 x109/L; ANC ≥ 1.5 x 109/L without the use of hematopoietic growth factors.
    2. Creatinine less than 2.5 times the upper limit of normal for the institution.
    3. AST and ALT less than 2.5 times the upper limit of normal for the institution.
  7. Able to understand and give written informed consent and comply with study procedures.

Exclusion Criteria:

  1. Discontinuation of AI therapy prior to study entry.
  2. Less than 3 months treatment with most recent AI.
  3. Rapidly progressive, life-threatening metastases, including any of the following:

    1. Symptomatic lymphangitic metastases.
    2. Patients with known active brain or leptomeningeal involvement.
  4. More than one prior chemotherapy for metastatic disease.
  5. Any chemotherapy within 3 months prior to study.
  6. Radiotherapy to measurable lesion within 2 months prior to study.
  7. Bisphosphonates initiated within 4 weeks prior to study start.
  8. Allergy to benzamides or inactive components of study drug.
  9. Previous treatment with entinostat or any other HDAC inhibitor including valproic acid.
  10. Patient is currently receiving treatment with any agent listed on the prohibited medication list such as valproic acid or other systemic cancer agents
  11. Any concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator:

    1. Myocardial infarction or arterial thromboembolic events within 6 months, or experiencing severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease and a QTc interval >0.47 second.
    2. Uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection,
    3. Other active malignancy within 5 years excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN / cervical carcinoma in situ] or melanoma in situ).
  12. Patient currently is enrolled in (or completed within 30 days before study drug administration) another investigational drug study.

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): NCT00828854

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St. Vincent's University Hospital
Dublin, Ireland
United Kingdom
The University of Birmingham
Birmingham, United Kingdom
Velindre Hospital - Whitchurch
Cardiff, United Kingdom
Whiston Hospital; Clatterbridge Centre for Oncology
Liverpool, United Kingdom
University College London Hospitals
London, United Kingdom
Christie Hospital, Manchester Breast Centre
Manchester, United Kingdom
Sponsors and Collaborators
Syndax Pharmaceuticals

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Responsible Party: Judy Billingsley, RN, BSN, OCN, Syndax Pharmaceuticals, Inc. Identifier: NCT00828854    
Other Study ID Numbers: SNDX-275-0303
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010
Keywords provided by Syndax Pharmaceuticals:
breast cancer
estrogen receptor postive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Histone Deacetylase Inhibitors