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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68849558

Enrollment

Registered

2013-09-16

Start date

2010-12-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary epithelial ovarian, fallopian tube or primary peritoneal carcinoma Cancer Other and unspecified female genital organs

Interventions

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 doxorubic

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Dose limiting toxicity (DLT) at each visit of cycle 1 and maximum tolerated dose (MTD) measured by Adverse Events monitoring 2. Safety profile at each visit measured by Adverse events monitoring	—

Secondary

Measure	Time frame
1. Tumour response evaluation every 2 cycles by imaging and every cycle by blood test 2. Pharmacokinetic and pharmacodynamic parameters during cycle1 measured using blood samples	—

Countries

Belgium, France, Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026