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

• Register: ISRCTN
• Last refreshed on: 21 May 2018
• Main ID: ISRCTN00759419
• Date of registration: 02/08/2013
• Prospective Registration: No
• Primary sponsor: Institut de Recherches Internationales Servier (France)
• Public title: Phase I dose-escalation study of S 49076 in patients with advanced solid tumours
• Scientific title: Phase I dose-escalation study of oral administration of MET Tyrosine Kinase Inhibitor S 49076 in patients with advanced solid tumours
• Date of first enrolment: 13/02/2012
• Target sample size: 110
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN00759419
• Study type: Interventional
• Study design: International multicentric non-randomised open-label dose escalation Phase I study (Treatment)
• Phase: Phase I

Countries of recruitment

France, Spain

Contacts

• Name: Antoine Hollebecque

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Advanced solid tumours
Cancer

Intervention(s)

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

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

CL1-49076-001

Source(s) of Monetary Support

Institut de Recherches Internationales Servier (France)

Ethics review

Status:
Approval date:
Contact:

Ethics approval was obtained before recruitment of the first participants

Results

• Results available: Yes
• Date Completed: 15/09/2014