Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CL1-78454-011
Study information
Scientific title
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
Acronym
Study hypothesis
To establish the safety profile and the recommended Phase II dose of S 78454 in combination with a fixed dose of tamoxifen 20 mg.
Ethics approval
Ethics approval was obtained before recruitment of the first participants
Study design
International multicentric non-randomised open dose-escalation Phase I study.
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Advanced breast cancer
Intervention
Capsules containing 20 mg and 100 mg of S 78454 / oral use / 120 mg b.i.d to 160 mg b.i.d (dose de-escalation up to 80 mg b.i.d can be performed), and
Fixed dose of tamoxifen 20 mg per day / oral use
Treatment duration is at the discretion of the investigator
Intervention type
Drug
Phase
Phase I
Drug names
S 78454, tamoxifen
Primary outcome measures
1. Dose limiting toxicities and maximum tolerated doses at the end of cycle 2. Methods used: blood samples, physical examination, vital signs assessment, ECG
2. Safety profile of the combination at each visit (adverse events, laboratory tests, physical examination, ECOG, vital signs, ECG)
Secondary outcome measures
1. Pharmacokinetic evaluation within cycle 2 by blood samples
2. Pharmacodynamic assessment every cycle by blood samples
3. Tumour response evaluation every two cycles according to RECIST criteria
Overall trial start date
30/08/2012
Overall trial end date
28/01/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
40 patients
Participant 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
Recruitment start date
30/08/2012
Recruitment end date
07/07/2014
Locations
Countries of recruitment
France, Italy, Spain
Trial participating centre
Institut Gustave Roussy
Villejuif
94805
France
Sponsor information
Organisation
Pharmacyclics LLC (USA)
Sponsor details
999 East Arques Avenue
Sunnyvale
94085
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Pharmacyclics LLC (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary