Condition category
Cancer
Date applied
03/04/2014
Date assigned
29/04/2014
Last edited
17/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Dr Suzette Delaloge

ORCID ID

Contact details

Institut Gustave Roussy
114 rue Edouard Vaillant
Villejuif
94805
France

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

www.pharmacyclics.com

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

Publication citations

Additional files

Editorial Notes

On 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.