EUCTR2019-000998-23-ES
Active, not recruiting
Phase 1
A Phase I/II, open label, non-randomized study to evaluate safety, tolerability, pharmacokinetics and clinical activity of S64315 in patients with locally advanced or metastatic breast cancer in combination with various standard treatments including hormonal and cytotoxic agents
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut de Recherches Internationales Servier
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In Arm 1: S64315 \+ paclitaxel
- •\-Histologically confirmed locally advanced or metastatic TNBC or HR\+/Her2\- (HR\+ (Estrogen or Progesterone) \> 10% and Her2\- (score 0 or 1 by immunochemistry), FISH BC (Fluorescence In Situ Hybridization) negative if IHC (immuno\-histochemistry) score 2\):
- •TNBC: no more than 2 prior chemotherapeutic regimens in the locally advanced or metastatic setting
- •HR\+/Her2\-: no more than 2 prior chemotherapeutic regimens and no more than 1 prior PI3K inhibitor (PIKi) in the locally advanced or metastatic setting
- •In Arm 2: S64315 \+ eribulin
- •\-Histologically confirmed locally advanced or metastatic TNBC or HR\+/Her2\- BC (HR\+ (Estrogen or Progesterone) \> 10% and Her2\- (score 0 or 1 by immunochemistry), FISH (Fluorescence In Situ Hybridization) negative if IHC (immuno\-histochemistry) score 2\):
- •TNBC: no more than 2 prior chemotherapeutic regimens in the locally advanced or metastatic setting
- •HR\+/Her2\-: no more than 2 prior chemotherapeutic regimens and no more than 1 prior PI3Ki in the locally advanced or metastatic setting
- •\-No prior exposure to eribulin in the adjuvant, neoadjuvant or metastatic setting
- •In Arm 3: S64315 \+ fulvestrant
Exclusion Criteria
- •\-Only for Arm 1 and 2: Pregnant and lactating women
- •\-Patients who have not recovered from toxicity of previous anticancer therapy, including grade \= 2 non\-haematologic toxicity, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI\-CTCAE, version 5\.00\), prior to the first IMP administration Certain toxicities will not be considered in this category (e.g. alopecia)
- •\-Severe or uncontrolled active acute or chronic infection
- •\-Known clinically significant history of liver disease consistent with Child\-Pugh Class B or C, active viral or other hepatitis or cirrhosis
- •\-Medical history of acute or chronic pancreatitis
- •\-Unresolved diarrhoea \= CTCAE Grade 2 or presence of medical condition associated with chronic diarrhoea (such as irritable bowel syndrome, inflammatory bowel disease)
- •\-Clinically significant cardiac dysfunction (including NYHA Class \= II heart failure, left ventricular ejection fraction (LVEF) \< 50% as assessed by echocardiography or Multi Gated Acquisition Scan (MUGA))
- •\-Uncontrolled arterial hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 95 mmHg despite treatment)
- •\-Acute coronary syndrome including unstable angina pectoris (anginal symptoms at rest), new onset angina, acute myocardial infarction, coronary artery bypass graft (CABG) within 3 months prior to starting study treatment
- •\-Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation), complete left bundle branch block, high\-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
Outcomes
Primary Outcomes
Not specified
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