A Phase II, Double-Blind, Placebo Controlled, Multi-Centre, Randomised Study of AZD0530 in Patients with Advanced Ovarian Cancer Sensitive to Platinum-Based Chemotherapy - (OVERT-1)
- Conditions
- advanced ovarian cancer sensitive to platinum based chemotherapyMedDRA version: 9.1Level: HLTClassification code 10033129Term: Ovarian neoplasms malignant (excl germ cell)
- Registration Number
- EUCTR2007-005325-30-DK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 220
1.Provision of signed, written informed consent
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
5.Radiological evidence of disease recurrence or progression at least 6 months following treatment cessation of first or second line platinum containing therapy (including platinum based maintenance therapy)
6.Documented non-measurable or measurable lesion according to RECIST criteria assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging
(MRI)
7.World Health Organisation (WHO) performance status 0 to 2
8.Estimated life expectancy of more than 12 weeks
9.Evidence of non-childbearing status: negative pregnancy test within 7 days of study treatment if of childbearing potential, or postmenopausal status (defined by any one of the following: natural menopause with last menses >1 year ago; radiation-induced oophorectomy with last menses >1 year ago, chemotherapy-induced menopause with >1 year interval since last menses) or surgical sterilisation (bilateral oophorectomy or hysterectomy)
10.For inclusion in the optional pharmacogenetic research, patients must fulfil the following criterion:
Provision of informed consent for pharmacogenetic research
If a patient declines to participate in the pharmacogenetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in the Clinical Study Protocol, so long as they 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 peritoneaum
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)
5.Inadequate bone marrow reserve as demonstrated either by an absolute neutrophil count <1.5 x 10 to the power of 9/L or platelet count <100 x 10 to the power of 9/L
6.Haemoglobin =9 g/dL (5.59 mMol/L)
7.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)
8.Patients with estimated GFR9.Last dose of anti-cancer therapy received within 14 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 effect, or known duration and time to reversibility of drug related AEs, as agreed upon by AstraZeneca and the Investigator
10.Received more than two previous chemotherapy regimens for treatment of ovarian cancer
11.Evidence of uncontrolled systemic conditions (eg, severe hepatic impairment, interstitial lung disease [bilateral, diffuse, parenchymal lung disease]) or 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
12.Any other concurrent condition which in the investigator’s opinion makes it
undesirable for the patient to participate in the trial or which would jeopardise
compliance with the protocol
13. Pregnant or breast-feeding women
14. Unwillingness to use an acceptable method of contraception while on study (for
women of child bearing potential) and for three months after cessation of dosing
with AZD0530/matching placebo. Post-menopausal status will be considered adequate evidence of
non-childbearing potential and is defined as any 1 of the following: natural
menopause with last menses >1 year ago, radiation induced oophorectomy with last
menses >1 year ago, chemotherapy-induced menopause with >1 year interval since
last menses or surgical sterilisation (bilateral oophorectomy or hysterectomy)
15. Unresolved toxicity =CTCAE grade 2 from previous anti-cancer therapy except
alopecia
16. Symptomatic peripheral neuropathy =NCIC-CTC grade II
17. Patients believed to have a known immunodeficiency syndrome
18. Resting ECG with measurable QTc interval of >480 msec at 2 or more time points
within a 24 hour period
19. Current use or previous use within specified time period (detailed in CSP Appendix E) of drugs or herbal supplements known to be potent inducers or inhibitors of CYP3A4
20. Known hypersensitivity to AZD0530, its excipients, or drugs in its class
21. Cannot be adequately followed up for the duration of their study participation.
22. Participation in another study with an investigational product within the previous 90 days or participation in a previous clinical study within 30 days prior to study entry
23. Risk (in the investigator’s opinion) of transmitting, through blood or other body
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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