Phase I dose-escalation study of S 49076 in patients with advanced solid tumours
| ISRCTN | ISRCTN00759419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00759419 |
| Secondary identifying numbers | CL1-49076-001 |
- 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
Scientific
Institut de Cancérologie Gustave Roussy
39 rue Camille Desmoulins
Villejuif
94805
France
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 |
| 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 |
| Completion date | 15/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
94805
France
Sponsor information
Institut de Recherches Internationales Servier (France)
Industry
Industry
50 rue Carnot
Suresnes
92284
France
| Website | http://www.servier.com/ |
|---|---|
"ROR" |
https://ror.org/034e7c066 |
Funders
Funder type
Industry
Institut de Recherches Internationales Servier (France)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Publication plan: Summary results are published in https://clinicaltrials.servier.com. |
| 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? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | results | 01/08/2017 | Yes | No |
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.
