Phase I dose-escalation study of S 78454 in patients with solid tumour
| ISRCTN | ISRCTN96863717 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96863717 |
| Secondary identifying numbers | CL1-78454-002 |
- Submission date
- 13/05/2013
- Registration date
- 06/08/2013
- 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
Prof Jean-Charles Soria
Scientific
Scientific
Institut de Cancérologie Gustave Roussy
39 rue Camille Desmoulins
Villejuif
94805
France
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Phase I dose-escalation study of oral administration of Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in patients with solid tumour |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 07/05/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Up to 60 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/02/2010 |
| Date of final enrolment | 07/05/2012 |
Locations
Countries of recruitment
- France
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 | 01/09/2013 | 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 sharing statement added.
29/11/2017: Results summary added.
17/12/2015: Sponsoring/funding responsibility for the S 78454 project was transferred from Servier, France to Pharmacyclics, USA on 23/11/2014. However, as this study had already been completed at this time, the sponsor/funder remains stated as Servier. However, in case of any questions, please contact Pharmacyclics (info@pcyc.com).
