Patients with Platinum-Resistant or Platinum-Refractory, Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy MedDRA version: 9.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Phenoxodiol
Product Code: NV-06
Pharmaceutical Form: Capsule*
INN or Proposed INN: Idronoxil
CAS Number: 81267-65-4
Current Sponsor code: NV-06
Concentration unit: mg milligram(s)
Concen
Sponsors
Marshall Edwards Pty Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Disease type (a) histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin; (b) recurrent or persistent advanced disease; (c) have measurable disease. [Measurable disease being defined as at least one lesion that can be accurately measured in at least one dimension, allowing a response to be determined by the RECIST criteria. Each lesion must be = 10 mm when measured by spiral CT and = 20 mm when measured by conventional CT]; Treatment response history (d) 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; (e) 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- or 3-weekly regimen and (f) have a 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; Treatment history (g) can have any number of previous courses of platinum therapy or non-platinum therapy; Clinical status (h) be considered likely to survive at least 3 months; (i) have a Karnofsky Performance Score of at least 60%; (j) have adequate physiological function without evidence of major organ dysfunction as evidenced by a serum creatinine = 1.5 mg/dl, serum transaminase levels =3 x the upper limit of normal (ULN) for the reference laboratory, and a bilirubin level = ULN; (k) have adequate hematological function defined by platelets > 100,000/ mm3, WCC > 3,000/mm3, neutrophils > 1,500 /mm3, hemoglobin> 8.0 g/dl; (l) Have a negative pregnancy test (HCG) in patients of childbearing potential Other (m)be aged > 18; and (n) be able to understand the risks and benefits of the study and give written informed consent to participation. 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
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will not be included in the study: a) patients with mucinous histological type of ovarian cancer; b) patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy; c) patients with active infection; d) patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.); e) patients with a history of chronic active hepatitis or cirrhosis; f) patients with HIV; g) 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; h) patients who have not recovered from the acute effects of any prior anti-neoplastic therapy; and i) patients with known hypersensitivity to platinum drugs that cannot be managed with concomitant medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of a treatment regimen of (i) daily phenoxodiol in combination with weekly carboplatin, versus (ii) weekly carboplatin therapy in combination with a placebo, on progression-free survival in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer.;Secondary Objective: To compare the effect of a treatment regimen of (i) daily phenoxodiol in combination with weekly carboplatin, versus (ii) weekly carboplatin therapy in combination with a placebo, on overall survival in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer. To compare the effect of the treatment regimen on overall response rates, duration of response, clinical status (Karnofsky Performance Score) and quality of life in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer. Primary safety objectives is: To compare the effect of the treatment regimen on drug-associated toxicity and intolerance in patients with platinum-resistant or platinum-refractory, late-stage epithelial ovarian, fallopian or primary peritoneal cancer.;Primary end point(s): Primary efficacy end-point: Progression-Free Survival (PFS)- defined as the time from randomization until objective tumor progression or death. PFS will be determined by measuring the time (in weeks) from randomization until the patient’s disease has progressed according to RECIST criteria, or in the event of death without disease progression. Secondary end-point Overall Survival (OS): defined as the time from randomization until death from any cause. Tertiary end-points: Overall Response Rate (ORR): defined as the incidence within either of the two treatment groups of patients showing a reduction in tumor burden as determined according to RECIST criteria. ORR is the number of subjects in each treatment g | — |
Countries
Belgium, Italy, Spain, United Kingdom
Outcome results
None listed