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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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21 May 2018 |
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Main ID: |
ISRCTN96863717 |
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Date of registration:
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06/08/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase I dose-escalation study of S 78454 in patients with solid tumour
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Scientific title:
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Phase I dose-escalation study of oral administration of Pan-Histone Deacetylase (HDAC) Inhibitor S 78454 in patients with solid tumour |
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Date of first enrolment:
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22/02/2010 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN96863717 |
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Study type:
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Interventional |
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Study design:
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Monocentric non-randomised non-comparative open Phase I study (Treatment)
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Phase:
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Phase I
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Countries of recruitment
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France
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Contacts
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Name:
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Jean-Charles
Soria |
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Address:
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Institut de Cancérologie Gustave Roussy
39 rue Camille Desmoulins
94805
Villejuif
France |
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Solid tumours
Cancer
Malignant neoplasm, unspecified
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Intervention(s)
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Capsules containing 20 mg and 100 mg / oral use / treatment duration is at the discretion of the investigator.
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Primary Outcome(s)
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1. Maximum tolerated dose (MTD)
2. Dose limiting toxicity (DLT) of S 78454. This is evaluated at the end of cycle 1.
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Secondary Outcome(s)
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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
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Secondary ID(s)
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CL1-78454-002
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
The Ethics committee Ile de France II (06/11/2009)
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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07/05/2012 |
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URL:
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