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
- Conditions
- Primary epithelial ovarian, fallopian tube or primary peritoneal carcinomaCancerOther and unspecified female genital organs
- Registration Number
- ISRCTN68849558
- Lead Sponsor
- Pharmacyclics LLC (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Dose limiting toxicity (DLT) at each visit of cycle 1 and maximum tolerated dose (MTD) measured by Adverse Events monitoring<br>2. Safety profile at each visit measured by Adverse events monitoring
- Secondary Outcome Measures
Name Time Method 1. Tumour response evaluation every 2 cycles by imaging and every cycle by blood test<br>2. Pharmacokinetic and pharmacodynamic parameters during cycle1 measured using blood samples