Condition category
Cancer
Date applied
02/09/2013
Date assigned
24/09/2013
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 Jean-Pierre Delord

ORCID ID

Contact details

Clinical Research Unit and Pharmacology Lab EA 3035
Institut Claudius Regaud
20-24
rue du Pont Saint Pierre
Toulouse
31052
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL1-78454-005

Study information

Scientific title

Phase I dose-escalation study of oral administration of S 78454 given with a fixed dose infusion of doxorubicin administered weekly 3 out of 4 weeks in patients with solid tumour

Acronym

Study hypothesis

To establish the safety profile and the recommended Phase II dose of S 78454 in combination with a fixed dose infusion of doxorubicin.

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

Multicentric non-randomised open dose escalation Phase I study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

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

1. Capsules containing 20 mg and 100 mg of S 78454 / Oral use / Treatment duration is 6 cycles
2. Fixed dose infusion of 25 mg/m² of doxorubicin, weekly 3 out of 4 weeks / Treatment duration is 6 cycles

No control group is involved

Intervention type

Drug

Phase

Phase I

Drug names

S 78454, doxorubicin

Primary outcome measures

1. Dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) at each visit - Methods used: blood samples, physical examination, electrocardiogram (ECG)
2. Safety profile of the combination at each visit

Secondary outcome measures

1. Tumour response at baseline evaluation every 2 cycles using the Response Evaluation Criteria In Solid Tumors (RECIST) guideline
2. Pharmacokinetic parameters during cycle 1 and 2 by blood samples
3. Pharmacodynamic parameters during cycle1 by blood samples and tumour biopsies

Overall trial start date

15/11/2010

Overall trial end date

15/11/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Solid tumour, with measurable or evaluable disease, that has relapsed or is refractory to conventional, standard forms of therapy
2. Ability to swallow oral capsule(s) without difficulty
3. Estimated life expectancy > 12 weeks
4. Eastern Cooperative Oncology Group (ECOG) performance status < or equal to 1
5. Adequate haematological, renal and hepatic functions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36 patients

Participant exclusion criteria

1. Major surgery within previous 4 weeks
2. Chemotherapy within previous 3 weeks (6 weeks in case of nitrosoureas)
3. Radiotherapy within previous 4 weeks (except for palliative radiotherapy at localised lesions)
4. Immunotherapy or hormonotherapy within previous 2 weeks, except stable oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, or oral contraceptives or hormonal replacement therapy
5. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes
6. Patients treated by valproic acid within previous 5 days
7. Phenytoin (and by extension fosphenytoin) within previous 3 weeks

Recruitment start date

15/11/2010

Recruitment end date

15/11/2013

Locations

Countries of recruitment

Belgium, France

Trial participating centre

Clinical Research Unit and Pharmacology Lab EA 3035
Toulouse
31052
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

Publication citations

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).