Phase I study of S 78454 given with a fixed dose infusion of pegylated liposomal doxorubicin in the treatment of primary epithelial ovarian, fallopian tube or primary peritoneal carcinoma
| ISRCTN | ISRCTN68849558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68849558 |
| Protocol serial number | CL1-78454-003 |
| Sponsor | Pharmacyclics LLC (USA) |
| Funder | Pharmacyclics LLC (USA) |
- Submission date
- 08/07/2013
- Registration date
- 16/09/2013
- Last edited
- 17/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Ignace Vergote
Scientific
Scientific
University Hospital Leuven (K.U.Leuven)
Gynaecological Oncology Herestraat 49
Leuven
3000
Belgium
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentric non-randomised open dose escalation Phase I study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Phase I study of oral administration of S 78454 given with a fixed dose infusion of pegylated liposomal doxorubicin in the treatment of primary platinum-resistant and partially platinum-sensitive, epithelial ovarian, fallopian tube or primary peritoneal carcinoma |
| Study objectives | To establish the safety profile and the recommended Phase II dose of S 78454 in combination with a fixed dose infusion of pegylated liposomal doxorubicin. On 13/11/2014 the anticipated end date was changed from 01/12/2014 to 30/12/2015. |
| Ethics approval(s) | Ethics approval was obtained before recruitment of the first participants |
| Health condition(s) or problem(s) studied | Primary epithelial ovarian, fallopian tube or primary peritoneal carcinoma |
| Intervention | 1. Capsules containing 20 mg and 100 mg of S 78454 administered orally. Treatment duration is at the discretion of the investigator. 2. Fixed dose infusion of 40 mg/m² of pegylated liposomal doxorubicin |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | S 78454 |
| Primary outcome measure(s) |
1. Dose limiting toxicity (DLT) at each visit of cycle 1 and maximum tolerated dose (MTD) measured by Adverse Events monitoring |
| Key secondary outcome measure(s) |
1. Tumour response evaluation every 2 cycles by imaging and every cycle by blood test |
| Completion date | 30/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 70 |
| Key inclusion criteria | 1. Female patient aged 18 years or above 2. Histologically confirmed diagnosis of advanced relapsed epithelial ovarian carcinoma, fallopian tube carcinoma or primary peritoneal carcinoma, with measurable and evaluable disease 3. Platinum resistant and partially platinum sensitive tumour 4. Ability to swallow oral capsule(s) without difficulty 5. Estimated life expectancy of more than 12 weeks 6. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 7. Adequate haematological, renal and hepatic functions |
| Key exclusion criteria | 1. Pregnant or breast-feeding women, women for whom fertility function has been preserved without effective contraception 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 oral glucocorticoid and mineralocorticoid replacement for adrenal insufficiency, stable mitotane for adrenal carcinoma or oral contraceptives or hormonal replacement therapy 6. Risk factors for, or use of drugs known to prolong QTc interval and that may be associated with Torsades de Pointes 7. Patients treated by valproic acid within previous 5 days before |
| Date of first enrolment | 01/12/2010 |
| Date of final enrolment | 30/12/2015 |
Locations
Countries of recruitment
- Belgium
- France
- Italy
Study participating centre
University Hospital Leuven (K.U.Leuven)
Leuven
3000
Belgium
3000
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
Sponsoring/funding responsibility for the S 78454 project was transferred from Servier, France to Pharmacyclics, USA on 23/11/2014.
