A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 plus Carboplatin and Paclitaxel or Placebo plus Carboplatin and Paclitaxel in Patients with Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy - ND
- Conditions
- Patients with Advanced Ovarian Cancer Sensitive to Platinum-based ChemotherapyMedDRA version: 12.1Level: LLTClassification code 10026310Term: Malignant neoplasm of ovary
- Registration Number
- EUCTR2008-006068-12-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 122
1. Provision of informed consent prior to any study specific procedures 2. Females aged 18 years and older 3. Histologically proven diagnosis of: - Epithelial ovarian carcinoma - Fallopian tube carcinoma - Primary serous peritoneal carcinoma 4. Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry with evidence of disease recurrence or progression at least 6 months following treatment cessation of first-line platinum-containing therapy and having stopped any maintenance therapy at least 30 days prior to trial entry (if applicable, excluding platinum-based maintenance therapy) 5. Radiologically documented measurable disease according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) or radiologically documented non-measurable (but evaluable) disease. A non-measurable but evaluable patient is defined as a patient with a non-measurable soft tissue lesion (this includes bone lesions) that can be determined according to RECIST and documented via a CT or MRI scan. Patients with ascites and/or pleural/pericardial effusion only, are not considered as evaluable in this study 6. World Health Organisation (WHO) performance status 0 to 2 7. Estimated life expectancy of more than 16 weeks 8. For inclusion in the optional biomarkers and pharmacogenetic research, patients must fulfil the following criterion: - Provision of a biomarker research informed consent for biomarkers and/or a pharmacogenetic research informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Clinical evidence of central nervous system (CNS) metastases 2.Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and mucinous carcinoma of the peritoneum 3.Tumour of borderline malignancy 4.A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) in the last 5 years 5.Inadequate bone marrow reserve as demonstrated either by an absolute neutrophil count <1.5 x 109/L or platelet count <100 x 109/L 6.Haemoglobin ≤9 g/dL (5.59 mMol/L) 7.Stage II, III or IV cardiac failure (classified according to New York Heart Association [NYHA] classification [see Appendix D]) or myocardial infarction within 6 months prior to study entry 8.Severe or frequent migrainous headaches 9.Inadequate liver function as demonstrated by serum bilirubin ≥2 times the upper limits of reference range (ULRR), alanine aminotransferase (ALT), aspartate aminotransferase (AST) or ALP ≥2.5 times the ULRR (ALP ≥5 times the ULRR if judged by the investigator to be related to liver metastases) 10.Patients with GFR<50 mL/min estimated using the Cockroft and Gault or Sanaka formula (for elderly pts [>60 yrs] with very low muscle mass and who do not have nephrotic syndrome or severe hepatic disease, Sanaka et al 1996, Appendix K); though patients found to have GFR over 50mL/min from 24 hour creatinine clearance measurement may be entered 11.Last dose of platinum chemotherapy received within 180 days or any other anti-cancer therapy (including maintenance therapy) received within 30 days prior to the first dose of treatment with study drug.If insufficient wash-out time has not occurred due to schedule or PK properties, a longer wash-out period will be required according to expected time to anti-tumour affect, or known duration and time to reversibility of drug related AEs, as agreed upon by AstraZeneca and the Investigator. 12.Received more than 1 previous chemotherapy regimens for treatment of ovarian cancer (maintenance chemotherapy after first-line treatment is acceptable excluding platinum-based chemotherapy, provided that it is stopped at least 30 days prior to the first dose of treatment with study drug) 13.Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment, current unstable or uncompensated respiratory or cardiac conditions) which makes it undesirable for the patient to participate in the study or which could jeopardise compliance with the protocol. 14.Any other concurrent condition which in the investigators opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol 15.Pregnant or breast-feeding women and women of child bearing potential.Women must either be of postmenopausal status (either natural menopause or following previous therapy and defined by any one of the following: absence of menses for 1 year, or LH, FSH and oestradiol all in the post-menopausal range) or surgically sterilised. 16.Unresolved toxicity ≥CTCAE grade 2 from previous anti-cancer therapy except alopecia 17.Symptomatic peripheral neuropathy ≥CTCAE grade 2 18.Patients believed to have a known immunodeficiency syndrome 19.Resting ECG with measurable QTc interval of >470 msec 20.Use of potent CYP3A4 inducers (such as phenytoin, rifampicin, carbamazepine, phenobarbitone and St Johns Wort) within 2 weeks of starting treatment 21.Known hypersensitivit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method