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

This study has been completed.
Sponsor:
Information provided by:
Syndax Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00828854
First received: January 23, 2009
Last updated: February 2, 2010
Last verified: February 2010

January 23, 2009
February 2, 2010
April 2008
February 2010   (final data collection date for primary outcome measure)
Clinical benefit rate (CBR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Clinical benefit rate (CBR) during the first 6 cycles of study treatment, i.e., CR/PR/SD ≥ 6 months, according to RECIST criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00828854 on ClinicalTrials.gov Archive Site
  • Progression free survival (PFS) [ Designated as safety issue: No ]
  • Objective response rate (ORR) during the first 6 cycles of study treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
ER+ Breast Cancer
Drug: entinostat (SNDX-275)
5 mg PO every week
Experimental: treatment
Continued treatment with same AI at labeled dose and schedule, plus Entinostat (5mg PO every week)
Intervention: Drug: entinostat (SNDX-275)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
February 2010   (final data collection date for primary outcome measure)

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.
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Ireland,   United Kingdom
 
NCT00828854
SNDX-275-0303
Yes
Judy Billingsley, RN, BSN, OCN, Syndax Pharmaceuticals, Inc.
Syndax Pharmaceuticals
Not Provided
Not Provided
Syndax Pharmaceuticals
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP