Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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 study
Study setting(s)
Other
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details 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
Pharmaceutical study type(s)
Phase
Phase I
Drug/device/biological/vaccine name(s)
S 49076
Primary outcome measure
1. Dose limiting toxicity (DLT) and maximum tolerated dose (MTD) at the end of the cycle 1, measured 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 study start date
13/02/2012
Overall study end date
15/09/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female patient aged 18 years or older
2. Advanced solid tumour 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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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
ROR
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
Publication plan:
Summary results are published in https://clinicaltrials.servier.com.
Intention to publish date
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from https://clinicaltrials.servier.com if a Marketing Authorisation has been granted after 1st January 2014.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/08/2017 | Yes | No |