Phase I dose-escalation study of S 49076 in patients with advanced solid tumours

ISRCTN	ISRCTN00759419
DOI	https://doi.org/10.1186/ISRCTN00759419
Protocol serial number	CL1-49076-001
Sponsor	Institut de Recherches Internationales Servier (France)
Funder	Institut de Recherches Internationales Servier (France)

Submission date: 11/06/2013
Registration date: 02/08/2013
Last edited: 18/04/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Antoine Hollebecque
Scientific

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

Study information

Primary study design	Interventional
Study design	International multicentric non-randomised open-label dose escalation Phase I study
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Phase I dose-escalation study of oral administration of MET Tyrosine Kinase Inhibitor S 49076 in patients with advanced solid tumours
Study objectives	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	S 49076
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	15/09/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	110
Key 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
Key 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
Date of first enrolment	13/02/2012
Date of final enrolment	15/09/2014

Locations

Countries of recruitment

France
Spain

Study participating centre

Institut de Cancérologie Gustave Roussy

Villejuif
94805
France

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2017		Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/04/2018: Internal review.
28/03/2018: Publication and dissemination plan and IPD sharing statement updated.
24/01/2018: Publication plan and IPD statement sharing added.
29/11/2017: Results summary added.
19/10/2017: Publication reference added.