Condition category
Cancer
Date applied
13/05/2013
Date assigned
06/08/2013
Last edited
17/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jean-Charles Soria

ORCID ID

Contact details

Institut de Cancérologie Gustave Roussy
39 rue Camille Desmoulins
Villejuif
94805
France

Additional identifiers

EudraCT 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

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

Trial setting

Not specified

Trial 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

Phase

Phase I

Drug names

Pan-Histone Deacetylase (HDAC) Inhibitor S 78454

Primary outcome measures

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 trial start date

22/02/2010

Overall trial end date

07/05/2012

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23790467

Publication citations

  1. Results

    Fouliard S, Robert R, Jacquet-Bescond A, du Rieu QC, Balasubramanian S, Loury D, Loriot Y, Hollebecque A, Kloos I, Soria JC, Chenel M, Depil S, Pharmacokinetic/pharmacodynamic modelling-based optimisation of administration schedule for the histone deacetylase inhibitor abexinostat (S78454/PCI-24781) in phase I., Eur. J. Cancer, 2013, 49, 13, 2791-2797, doi: 10.1016/j.ejca.2013.05.009.

Additional files

Editorial Notes

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).