Phase I study of oral administration of S 78454 in association with doxorubicin in patients with solid tumour
| ISRCTN | ISRCTN55052510 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55052510 |
| Secondary identifying numbers | CL1-78454-005 |
- Submission date
- 02/09/2013
- Registration date
- 24/09/2013
- 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
Dr Jean-Pierre Delord
Scientific
Scientific
Clinical Research Unit and Pharmacology Lab EA 3035
Institut Claudius Regaud
20-24, rue du Pont Saint Pierre
Toulouse
31052
France
Study information
| Study design | Multicentric non-randomised open dose escalation Phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| 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 S 78454 given with a fixed dose infusion of doxorubicin administered weekly 3 out of 4 weeks in patients with solid tumour |
| Study objectives | 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(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | S 78454, doxorubicin |
| Primary outcome measure | 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 study start date | 15/11/2010 |
| Completion date | 15/11/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/11/2010 |
| Date of final enrolment | 15/11/2013 |
Locations
Countries of recruitment
- Belgium
- France
Study participating centre
Clinical Research Unit and Pharmacology Lab EA 3035
Toulouse
31052
France
31052
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 |
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).
