Condition category
Cancer
Date applied
08/07/2013
Date assigned
30/08/2013
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

Dr Eric Deutsch

ORCID ID

Contact details

Institut de Cancérologie Gustave Roussy
39 rue Camille Desmoulins
Villejuif
94 805
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL1-78454-004

Study information

Scientific title

Phase I dose-escalation study of oral administration of the Pan-Histone Deacetylase (HDAC) inhibitor S 78454 in combination with standard hypofractionated radiotherapy in patients with advanced solid tumour

Acronym

Study hypothesis

To establish the safety profile and the recommended Phase II dose of S 78454 in combination with radiotherapy

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

International multicentric non-randomised open-label dose escalation Phase I study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

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 of S 78454 administered orally. Treatment duration is at the discretion of the investigator.

Intervention type

Drug

Phase

Phase I

Drug names

S 78454

Primary outcome measures

Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) at the end of cycle measured by adverse events monitoring

Secondary outcome measures

1. Safety profile at each visit measured by adverse events monitoring
2. Tumour response evaluation at baseline and at the final visit measured by imaging and blood tests
3. Tumour perfusion measurements only for schedule 1 using functional imaging
4. Exploration of changes in biological markers (optional part in schedule 1) using biopsies

Overall trial start date

02/09/2010

Overall trial end date

07/08/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Solid tumour, with measurable or evaluable disease, requiring a course of hypofractionated radiotherapy
2. Ability to swallow oral capsule(s) without difficulty
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
4. Estimated life expectancy of more than 20 weeks
5. Adequate haematological, renal and hepatic functions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

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. Previous radiotherapy on the same area
5. Cumulative radiation therapy involving more than 25% of the total bone marrow
6. 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
7. Concurrent therapeutic anticoagulation by Vitamin K antagonists
8. Patients treated by valproic acid
9. Risk factors for, or use of medications known to prolong QTc interval and that may be associated with Torsades de Pointes.

Recruitment start date

02/09/2010

Recruitment end date

04/02/2015

Locations

Countries of recruitment

France, Italy

Trial participating centre

Institut de Cancérologie Gustave Roussy
Villejuif
94 805
France

Sponsor information

Organisation

Pharmacyclics LLC (USA)

Sponsor details

999 East Arques Avenue
Sunnyvale
94085
United States of America

Sponsor type

Industry

Website

www.pharmacyclics.com

Funders

Funder type

Industry

Funder name

Pharmacyclics LLC (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The CSR will be written by Pharmacyclics in 2016

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 17/12/2015 the following changes were made to the trial record: 1. Sponsoring/funding responsibility for the S 78454 project was transferred from Servier, France to Pharmacyclics, USA on 23/11/2014. 2. The overall trial end date was changed from 21/12/2015 to 07/08/2015.