ISRCTN25889030
Completed
Phase 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 enrollmentApril 29, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pharmacyclics LLC (USA)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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