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Trial registered on ANZCTR


Registration number
ACTRN12606000471583
Ethics application status
Approved
Date submitted
27/10/2006
Date registered
14/11/2006
Date last updated
15/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
OVATURE (OVArian TUmor REsponse) study
Scientific title
Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol (Oral Dosage Form) in Combination with Carboplatin versus Carboplatin with Placebo in Patients with Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy
Universal Trial Number (UTN)
Trial acronym
OVATURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial ovarian, fallopian or primary peritoneal cancer that is resistant or refractory to 2-weekly, 3- or 4-weekly platinum drug therapy 1448 0
Condition category
Condition code
Cancer 1543 1543 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group The Phenoxodiol oral dose will be 2x200mg capsules taken 8 hourly (three times per day). Patients will receive carboplatin at a dosage of (Area Under the Curve) AUC=2, administered by intravenous injection once a week. Carboplatin will be administered weekly as a change in regimen from 3-weekly to weekly has been shown with taxanes to provide tumor response in patients whose tumors have become resistant to a 3-weekly regimen. The OVATURE study will compare Phenoxodiol (in the oral dosage form) combined with Carboplatin against Placebo combined with Carboplatin. The duration of each treatment cycle will be 4 weeks and there is no limit to the number of treatment cycles that can be administered. The expected overall trial completion date is March 2010. Treatment cycles will be discontinued in the case of unacceptable toxicity, disease progression, patient voluntary withdrawal, or if the Investigator or Sponsor asks for the patient to be withdrawn.
Intervention code [1] 1377 0
Treatment: Drugs
Comparator / control treatment
Control group The Placebo (sugar pill) oral dose will be 2x200mg capsules taken 8 hourly (three times per day). All patients will receive carboplatin at a dosage of AUC=2(Area Under the Curve), administered by intravenous injection once a week. There is no maximum or minimum limit to the number of cycles a patient may undertake, however patient may withdraw at any time for any reason. Therefore, the control group will continue through cycles from 10/2006 until 03/2010 taking placebo unless the subject withdraws or is asked to withdraw.
Control group
Placebo

Outcomes
Primary outcome [1] 2131 0
Progression-free survival (PFS)
Timepoint [1] 2131 0
From time of randomisation until disease progression (CT scan every 8 weeks, cancer tumour marker (CA125) measured every 2 weeks)
Primary outcome [2] 2132 0
Drug-associated toxicity and intolerance
Timepoint [2] 2132 0
Medical examination at screening, every 4 weeks and at end of study; Electrocardiogram (ECG) at screening and end of treatment visit; blood tests at screening, every week and at end of study.
Secondary outcome [1] 3690 0
Secondary Efficacy: Overall survival
Timepoint [1] 3690 0
From randomisation until patient death from any cause
Secondary outcome [2] 3691 0
Tertiary Efficacy: Overall response rate
Timepoint [2] 3691 0
CT scan taken every 8 weeks
Secondary outcome [3] 3692 0
Duration of response
Timepoint [3] 3692 0
CT scan taken every 8 weeks
Secondary outcome [4] 3693 0
Clinical status evaluated by Karnofsky Performance Score
Timepoint [4] 3693 0
Screening visit, every 4 weeks, at the end of treatment and 4 weeks post-treatment
Secondary outcome [5] 3694 0
Quality of life
Timepoint [5] 3694 0
At screening visit, every 8 weeks, end of treatment and 4 weeks post treatment.

Eligibility
Key inclusion criteria
1) histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin; 2) recurrent or persistent advanced disease; 3) have measurable disease; 4) Treatment response history; 5) undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded to the first of those courses of therapy as determined by either RECIST or GCIG criteria; 6)shown disease relapse as determined by either RECIST or GCIG criteria within 6 months of completion of the second or greater course of platinum therapy using a 2-3 or 4 -weekly regimen and have a platinum-free interval of no greater than 6 months at the time of enrollment; 7) can have any number of previous courses of platinum therapy or non-platinum therapy; 8) be considered likely to survive at least 3 months; 9) have a Karnofsky Performance Score of at least 60%; 10) have adequate physiological function without evidence of major organ dysfunction; 11) have adequate hematological function defined by platelets > 100,000/ mm3, WCC > 3,000/mm3, neutrophils > 1,500 /mm3, hemoglobin more than or equal to 8.0 g/dl; 12) Have a negative pregnancy test (HCG) in patients of childbearing potential 13) be aged 18 or older and be able to understand the risks and benefits of the study and give written informed consent to participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) patients with mucinous histological type of ovarian cancer; 2) patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy; 3) patients with active infection; 4) patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.); 5) patients with a history of chronic active hepatitis or cirrhosis; 6) patients with HIV; 7) patients with active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks; 8) patients who have not recovered from the acute effects of any prior anti-neoplastic therapy; 9) and patients with known hypersensitivity to platinum drugs drugs that can not be managed with concomitant medication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by Phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block Randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects, doctors/investigators, nurses, study coordinators, pharmacists, sponsor of drug, data management
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
340
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment outside Australia
Country [1] 398 0
United States of America
State/province [1] 398 0
TX, CA, NJ, KS, CT, TN, UT, OH, VA, NV, GA, MI, NC, NY, NM, AZ, LA
Country [2] 399 0
Belgium
State/province [2] 399 0
Leuven, Edegam
Country [3] 400 0
Poland
State/province [3] 400 0
Gdansk, Bialystok, Krakow, Warszawa, Gliwice, Poznan,
Country [4] 401 0
United Kingdom
State/province [4] 401 0
Glasgow, Wirral, Birmingham, Edinburgh, London, Nottingham, Sutton, Leeds, Somerset, Dundee,
Country [5] 402 0
Spain
State/province [5] 402 0
Barcelona, Alincante, Valencia,

Funding & Sponsors
Funding source category [1] 1683 0
Commercial sector/Industry
Name [1] 1683 0
Marshall Edwards Pty Ltd
Country [1] 1683 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Marshall Edwards Pty Ltd
Address
140 Wicks Rd
North Ryde 2113
Country
Australia
Secondary sponsor category [1] 1485 0
None
Name [1] 1485 0
Nil
Address [1] 1485 0
Country [1] 1485 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3129 0
Brisbane Mater Hospital
Ethics committee address [1] 3129 0
Ethics committee country [1] 3129 0
Australia
Date submitted for ethics approval [1] 3129 0
Approval date [1] 3129 0
26/09/2006
Ethics approval number [1] 3129 0
989A
Ethics committee name [2] 3130 0
Royal Adelaide Hospital
Ethics committee address [2] 3130 0
Ethics committee country [2] 3130 0
Australia
Date submitted for ethics approval [2] 3130 0
Approval date [2] 3130 0
28/09/2006
Ethics approval number [2] 3130 0
060824
Ethics committee name [3] 3131 0
Prince of Wales Hospital Randwick
Ethics committee address [3] 3131 0
Ethics committee country [3] 3131 0
Australia
Date submitted for ethics approval [3] 3131 0
Approval date [3] 3131 0
05/10/2006
Ethics approval number [3] 3131 0
06/143
Ethics committee name [4] 3132 0
Royal Womens Hospital Melbourne(not currently recruiting)
Ethics committee address [4] 3132 0
Ethics committee country [4] 3132 0
Australia
Date submitted for ethics approval [4] 3132 0
Approval date [4] 3132 0
16/10/2006
Ethics approval number [4] 3132 0
06/29
Ethics committee name [5] 3133 0
Westmead Hospital
Ethics committee address [5] 3133 0
Ethics committee country [5] 3133 0
Australia
Date submitted for ethics approval [5] 3133 0
Approval date [5] 3133 0
25/10/2006
Ethics approval number [5] 3133 0
2006/7/4.4(2382)
Ethics committee name [6] 5375 0
Royal North Shore Hospital
Ethics committee address [6] 5375 0
Ethics committee country [6] 5375 0
Australia
Date submitted for ethics approval [6] 5375 0
Approval date [6] 5375 0
11/03/2008
Ethics approval number [6] 5375 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27604 0
Address 27604 0
Country 27604 0
Phone 27604 0
Fax 27604 0
Email 27604 0
Contact person for public queries
Name 10566 0
Alan Husband
Address 10566 0
140 Wicks Rd
North Ryde NSW 2113
Country 10566 0
Australia
Phone 10566 0
+61 2 98780088
Fax 10566 0
+61 2 98780055
Email 10566 0
drugtrials@novogen.com
Contact person for scientific queries
Name 1494 0
Alan Husband
Address 1494 0
140 Wicks Rd
North Ryde NSW 2113
Country 1494 0
Australia
Phone 1494 0
+61 2 98780088
Fax 1494 0
+61 2 98780055
Email 1494 0
drugtrials@novogen.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.