Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL1-78454-002
Study information
Scientific title
Phase I dose-escalation study of oral administration of Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in patients with solid tumour
Acronym
Study hypothesis
To establish the safety profile, the optimal administration schedule and the recommended Phase II dose of S 78454 in patients with solid tumour.
Ethics approval(s)
The Ethics committee Ile de France II (06/11/2009)
Study design
Monocentric non-randomised non-comparative open Phase I study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Solid tumours
Intervention
Capsules containing 20 mg and 100 mg / oral use / 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)
Pan-Histone Deacetylase (HDAC) Inhibitor S 78454
Primary outcome measure
1. Maximum tolerated dose (MTD)
2. Dose limiting toxicity (DLT) of S 78454. This is evaluated at the end of cycle 1.
Secondary outcome measures
1. Safety profile at each visit
2. Pharmacokinetics (PK) and pharmacodynamics (PD) parameters: PK parameters are evaluated in cycle 1, and PD parameters during cycle 1, cycle 2 and cycle 3
3. Tumour response at baseline and every 2 cycles
Overall study start date
22/02/2010
Overall study end date
07/05/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female patient aged > or equal to 18
2. Solid tumour with measurable or evaluable disease, that has relapsed or is refractory to conventional standard forms of therapy
3. Ability to swallow oral capsule(s) without difficulty
4. Estimated life expectancy > 12 weeks
5. Eastern Cooperative Oncology Group (ECOG) performance status less 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
Up to 60 patients
Participant exclusion criteria
1. Allogenic bone marrow transplant
2. Major surgery within previous 4 weeks
3. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
4. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
5. Immunotherapy or hormonotherapy within previous 2 weeks, except stable luteinizing hormone-releasing hormone (LHRH) agonist therapy for prostate cancer, stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, stable mitotane for adrenal carcinoma, or oral contraceptives
6. Concurrent therapeutic anticoagulation by anti-vitamin K (AVK)
7. Patients treated by valproic acid
8. Any other previous (in the last 3 years) or concurrent cancer, other than resected non-melanoma skin cancer or cancer in situ of the uterine cervix
9. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
Recruitment start date
22/02/2010
Recruitment end date
07/05/2012
Locations
Countries of recruitment
France
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 | 01/09/2013 | Yes | No |