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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00382811




Registration number
NCT00382811
Ethics application status
Date submitted
28/09/2006
Date registered
2/10/2006
Date last updated
18/07/2016

Titles & IDs
Public title
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
Scientific title
Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol 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
Secondary ID [1] 0 0
NV06-0039
Universal Trial Number (UTN)
Trial acronym
OVATURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fallopian Tube Cancer 0 0
Peritoneal Neoplasms 0 0
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - phenoxodiol
Treatment: Drugs - carboplatin
Treatment: Drugs - placebo

Experimental: 1 - Daily Phenoxodiol + weekly carboplatin

Active Comparator: 2 - Daily phenoxodiol placebo + weekly carboplatin


Treatment: Drugs: phenoxodiol
400mg phenoxodiol three times daily in 28 day cycles.

Treatment: Drugs: carboplatin
AUC=2 weekly in 28 day cycles

Treatment: Drugs: placebo
every 8 hours daily in 28 day cycles
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
Timepoint [1] 0 0
Progression Free Survival
Secondary outcome [1] 0 0
The secondary efficacy end-point is overall survival (OS)
Timepoint [1] 0 0
Overall survival

Eligibility
Key inclusion criteria
- Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of
epithelial origin

- Recurrent or persistent advanced disease

- Have measurable disease

- 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 Response Evaluation Criteria in Solid Tumors (RECIST) or Gynecologic Cancer
Intergroup (GCIG) criteria

- 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 platinum-free interval of no greater than 6 months at the time of
enrollment, being the time taken from the last day of platinum therapy

- Any number of previous courses of platinum therapy or non-platinum therapy

- Likely to survive at least 3 months

- Karnofsky performance score of at least 60%

- Have adequate physiological function without evidence of major organ dysfunction as
evidenced by:

- serum creatinine < 1.5 mg/dl

- serum transaminase levels = 3 x the upper limit of normal (ULN) for the reference
laboratory and

- bilirubin level < ULN

- Have adequate hematological function defined by:

- platelets > 100,000/mm3

- white cell counts (WCC) > 3,000/mm3

- neutrophils > 1,500/mm3

- hemoglobin > 8.0 g/dl

- Aged > 18

- 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
- Patients with mucinous histological type of ovarian cancer

- Patients who have failed to show a clinical response (RECIST or GCIG criteria) to at
least one prior course of platinum therapy

- Patients with active infection

- Patients with concurrent severe and/or uncontrolled medical disease (e.g.,
uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure,
etc.)

- Patients with a history of chronic active hepatitis or cirrhosis

- Patients with HIV

- Patients with active central nervous system (CNS) metastases. Patients with known CNS
metastases must have received prior radiation therapy, and CNS metastatic disease must
be stable for 4 weeks.

- Patients who have not recovered from the acute effects of any prior anti-neoplastic
therapy

- Patients with known hypersensitivity to platinum drugs that cannot 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2011
Sample size
Target
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Mater Adult Hospital - Brisbane
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
- Westmead
Recruitment postcode(s) [4] 0 0
- Brisbane
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Belgium
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Edegem
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Belgium
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Leuven
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Italy
State/province [21] 0 0
Milano
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Italy
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Roma
Country [23] 0 0
Poland
State/province [23] 0 0
Bialystok
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Poland
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Gdansk
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Poland
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Gliwice
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Poznan
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Poland
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Warszawa
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Spain
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Barcelona
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Spain
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Alicante
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Spain
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Valencia
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United Kingdom
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Somerset
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United Kingdom
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Birmingham
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United Kingdom
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Dundee
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Nottingham
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United Kingdom
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Sutton
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United Kingdom
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MEI Pharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in
combination with weekly carboplatin, is effective against late stage ovarian cancer and to
see what, if any, side-effects of treatment may result.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00382811
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel P Gold, PhD
Address 0 0
MEI Pharma, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00382811