Phase I study of S 78454 in combination with radiotherapy in patients with solid tumour
| ISRCTN | ISRCTN48760309 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48760309 |
| Secondary identifying numbers | CL1-78454-004 |
- Submission date
- 08/07/2013
- Registration date
- 30/08/2013
- Last edited
- 22/02/2019
- 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 Eric Deutsch
Scientific
Scientific
Institut de Cancérologie Gustave Roussy
39 rue Camille Desmoulins
Villejuif
94 805
France
Study information
| Study design | International multicentric non-randomised open-label dose escalation Phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| 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 the Pan-Histone Deacetylase (HDAC) inhibitor S 78454 in combination with standard hypofractionated radiotherapy in patients with advanced solid tumour |
| Study objectives | To establish the safety profile and the recommended Phase II dose of S 78454 in combination with radiotherapy |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Solid tumours |
| Intervention | Capsules containing 20 mg of S 78454 administered orally. Treatment duration is at the discretion of the investigator. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Abexinostat (S 78454) |
| Primary outcome measure | 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 study start date | 02/09/2010 |
| Completion date | 07/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 90 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 02/09/2010 |
| Date of final enrolment | 04/02/2015 |
Locations
Countries of recruitment
- France
- Italy
Study participating centre
Institut de Cancérologie Gustave Roussy
Villejuif
94 805
France
94 805
France
Sponsor information
Pharmacyclics LLC (USA)
Industry
Industry
999 East Arques Avenue
Sunnyvale
94085
United States of America
| Website | www.pharmacyclics.com |
|---|---|
"ROR" |
https://ror.org/03hm8w204 |
Funders
Funder type
Industry
Pharmacyclics LLC (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | The CSR will be written by Pharmacyclics in 2016 |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/12/2016 | Yes | No |
Editorial Notes
22/02/2019: The following changes have been made to the trial record:
1. Publication reference added.
2. Abexinostat has been added as a drug name.
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.
