Phase I study of S 78454 with tamoxifen 20 mg in patients with breast cancer
| ISRCTN | ISRCTN25889030 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25889030 |
| Secondary identifying numbers | CL1-78454-011 |
- Submission date
- 03/04/2014
- Registration date
- 29/04/2014
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Dr Suzette Delaloge
Scientific
Scientific
Institut Gustave Roussy
114 rue Edouard Vaillant
Villejuif
94805
France
Study information
| Study design | International multicentric non-randomised open dose-escalation Phase I study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | S 78454, tamoxifen |
| Primary outcome measure | 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 study start date | 30/08/2012 |
| Completion date | 28/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 40 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 30/08/2012 |
| Date of final enrolment | 07/07/2014 |
Locations
Countries of recruitment
- France
- Italy
- Spain
Study participating centre
Institut Gustave Roussy
Villejuif
94805
France
94805
France
Sponsor information
Pharmacyclics LLC (USA)
Industry
Industry
999 East Arques Avenue
Sunnyvale
94085
United States of America
| Website | www.pharmacyclics.com |
|---|---|
"ROR" |
https://ror.org/03hm8w204 |
Funders
Funder type
Industry
Pharmacyclics LLC (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
29/05/2020: No publications found.
17/12/2015: The following changes were made to the trial record:
1. Sponsoring/funding responsibility for the S 78454 project was transferred from Servier, France to Pharmacyclics, USA on 23/11/2014.
2. The overall trial end date was changed from 31/12/2015 to 28/01/2015.
