ISRCTN25889030CompletedPhase 1
Phase I dose-escalation study of oral administration of S 78454 given with tamoxifen 20 mg in the treatment of patients with advanced breast cancer
Pharmacyclics LLC (USA)0 sites40 target enrollmentStarted: April 29, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Female patients aged 18 years or over
- •2. Ability to swallow oral capsule(s)
- •3. Estimated life expectancy > 12 weeks
- •4. ECOG performance status less than or equal to 1
- •5. Adequate haematological and hepatic functions
- •6. Histologically confirmed primary adenocarcinoma of the breast
- •7. Patients whose tumor has significant expression of Estrogen Receptor
- •8. Absence of Human Epidermal Growth Factor Receptor-2 overexpression or amplification
Exclusion Criteria
- •1. Major surgery within previous 4 weeks
- •2. Any previous chemotherapy within 3 weeks (6 weeks in case of nitroso-ureas) before starting the study drug
- •3. Any radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
- •4. Any other prior therapy directed at breast cancer within previous 3 weeks, including biologic/targeted therapy or immunologic agents
- •5. Hormonotherapy within 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, topical corticosteroids (e.g. cream, spray)
- •6. Concomitant uncontrolled infection or systemic disease
- •7. Known endometrial hyperplasia, or endometrial cancer
- •8. Patients with prior thromboembolic events or at high risk of such events
- •9. Rapidly progressive visceral, central nervous system, or liver metastases or significant symptomatic lymphangitic pulmonary metastases
- •10. Patients with pre-existing gastrointestinal disorders (including significant malabsorption syndrome, significant chronic digestive or gastrointestinal inflammatory syndrome, gastroduodenal disorders at risk for bleeding) that might interfere with proper absorption of the oral drugs
- •11. Patients with impaired cardiac function
Investigators
Similar Trials
Completed
Phase 1
Phase I study of oral administration of S 78454 in association with doxorubicin in patients with solid tumourSolid tumoursMalignant neoplasm, unspecifiedCancerISRCTN55052510Institut de Recherches Internationales Servier (France)36
Completed
Phase 1
Phase I dose-escalation study of oral administration of S55746 in patients with B-Cell Non-Hodgkin LymphomaChronic Lymphocytic Leukaemia (CLL) and B-Cell Non-Hodgkin Lymphoma (NHL) including Follicular Lymphoma (FL) , Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma and and Multiple myeloma (MM)Chronic Lymphocytic Leukaemia (CLL) and B-Cell Non-Hodgkin Lymphoma (NHL) including Follicular Lymphoma (FL) , Mantle Cell Lymphoma (MCL), Diffuse Large B-Cell Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Multiple myeloma (MM)CancerISRCTN04804337Institut de Recherches Internationales Servier (France)120
Completed
Phase 1
Phase I study of S 78454 in combination with a fixed dose infusion of cisplatin in patients with advanced solid tumoursCancerISRCTN85966108Institut de Recherches Internationales Servier (France)50
Completed
Phase 1
Oral administration of S 78454 in combination with cisplatin in patients with advanced non-keratinising nasopharyngeal carcinomaAdvanced non-keratinising nasopharyngeal carcinomaCarcinoma in situ of oral cavity and pharynxCancerISRCTN96922360Institut de Recherches Internationales Servier (France)40
Active, not recruiting
Phase 1
Phase I/II dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in Hodgkin’s Disease, non-Hodgkin Lymphoma and Chronic Lymphocytic LeukaemiaHodgkin's disease (HD) , non-Hodgkin lymphoma (NHL) and chronic lymphocytic Leukaemia (CLL)MedDRA version: 12.0Level: LLTClassification code 10020206Term: Hodgkin's diseaseMedDRA version: 12.0Level: LLTClassification code 10029547Term: Non-Hodgkin's lymphomaMedDRA version: 12.0Level: LLTClassification code 10008993Term: Chronic lymphoid leukaemiaEUCTR2009-013691-47-FRInstitut de Recherches Internationales Servier