Condition category
Cancer
Date applied
11/06/2013
Date assigned
02/08/2013
Last edited
01/11/2013
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 Antoine Hollebecque

ORCID ID

Contact details

Institut de Cancérologie Gustave Roussy
39 rue Camille Desmoulins
Villejuif
94805
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL1-49076-001

Study information

Scientific title

Phase I dose-escalation study of oral administration of MET Tyrosine Kinase Inhibitor S 49076 in patients with advanced solid tumours

Acronym

Study hypothesis

To establish the safety profile and the recommended dose of S 49076 with the selected treatment schedule.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

International, multicentric, non-randomised, open-label dose escalation Phase I study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Not specified

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 solid tumours

Intervention

Capsules containing 7.5 mg and 30 mg of S 49076 administered orally. Treatment duration is at the discretion of the investigator

Intervention type

Drug

Phase

Phase I

Drug names

S 49076

Primary outcome measures

1. Dose limiting toxicity (DLT) and maximum tolerated dose (MTD) at the end of the cycle 1, measure by AE
2. Safety profile at each visit, measured by AE monitoring

Secondary outcome measures

1. Pharmacokinetic evaluation within cycles 1 and 2: blood samples
2. Pharmacodynamic evaluation at each cycle: blood samples
3. Tumour response evaluation every two cycles: imagery

Overall trial start date

13/02/2012

Overall trial end date

15/09/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female patient aged 18 years or older
2. Advanced solid tumours, that has relapsed or is refractory to standard therapy or for which no effective standard therapy is available
3. Ability to swallow oral capsule(s)
4. Estimated life expectancy of more than 12 weeks
5. ECOG performance status less than or equal to 1
6. Adequate haematological, renal and hepatic functions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

110

Participant exclusion criteria

1. Major surgery within 4 weeks prior to the first day of the study drug administration
2. Chemotherapy within 3 weeks prior to the first day of the study drug administration (6 weeks in the case of treatment with nitroso-ureas)
3. Any other prior therapy involving an agent directed to the solid tumours within five times of the half-life of said agent but not less than 3 weeks prior to the first day of study drug administration
4. Hormonal therapy directed to the solid tumours within 2 weeks prior to the first day of study drug administration (6 weeks in the case of treatment with bicalutamide), except in the case of LHRH agonist therapy for prostate cancer which is permitted.
5. Radiotherapy within 4 weeks prior to the first day of the study drug administration (within 1 week in the case of palliative radiotherapy at localised lesions)
6. Cumulative radiation therapy involving more than 25% of the total bone marrow
7. Concomitant uncontrolled infection or severe systemic disease (at the discretion of the investigator)
8. Known organ dysfunction which would either compromise the patient's safety or interfere with the evaluation of the study drug safety
9. Patients with impaired cardiac function

Recruitment start date

13/02/2012

Recruitment end date

15/09/2014

Locations

Countries of recruitment

France, Spain

Trial participating centre

Institut de Cancérologie Gustave Roussy,
Villejuif
94805
France

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

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