ER+ Breast Cancer MedDRA version: 9.1 Level: LLT Classification code 10006202 Term: Breast cancer stage IV
Conditions
Interventions
Product Name: SNDX-275
Product Code: SNDX-275
Pharmaceutical Form: Coated tablet
INN or Proposed INN: entinostat
Current Sponsor code: S
Sponsors
Syndax Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Postmenopausal female patients. 2. Histolologically 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: a) Hemoglobin = 9.0 g/dL; platelets = 100 x109/L; ANC = 1.5 x 109/L without the use of hematopoietic growth factors. b) Creatinine less than 2.5 times the upper limit of normal for the institution. c) 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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: a) Symptomatic lymphangitic metastases. b) 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 SNDX-275 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, other systemic cancer agents (with the exception of approved luteinising-hormone releasing hormone (LHRH) agonists such as godserelin or leuproelin. See Section 6.6 for complete list. 11. Any concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases patient risk in the opinion of the investigator: a) 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. b) Uncontrolled heart failure or hypertension, uncontrolled diabetes mellitus, uncontrolled systemic infection, c) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the tumor responses to SNDX-275 in combination with continued AI therapy as measured by clinical benefit rate (CBR) during the first 6 cycles of study treatment, i.e., complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months.; Secondary Objective: Efficacy: To evaluate progression free survival (PFS) and objective response rates (ORR) of SNDX-275 during the first 6 cycles of study treatment when administered in combination with continued AI. Safety: To evaluate the safety and tolerability of SNDX-275 when administered in combination with continued AI therapy as measured by clinical adverse events and laboratory parameters. ;Primary end point(s): Clinical benefit rate (CBR) during the first 6 cycles of study treatment, i.e., CR/PR/SD = 6 months, according to RECIST criteria. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed