E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Platinum-Resistant or Platinum-Refractory, Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy
Cáncer epitelial de ovario, cáncer de trompas de Falopio o cáncer peritoneal primario que sean resistentes o refractarios al tratamiento con fármacos de platino dos o tres veces por semana.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029104 |
E.1.2 | Term | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 group with complete or partial response. Duration of Response: defined as the time from response (according to standard RECIST criteria) until disease progression (according to standard RECIST criteria) and will be measured in weeks. Clinical Status: determined on the basis of Karnofsky Performance Score for each patient measured at baseline, at the conclusion of each treatment cycle, at the end of treatment, and again at the end of study (4 weeks post completion of treatment). Quality of Life: determined on the basis of QOL FACT-O and FACT-BRM questionnaires for each patient measured at baseline, at the conclusion of every 2 treatment cycles and at the end of treatment.
Safety endpoints are: adverse events, physical and neurological examinations, ECG's, serum chemistry and hematology and coagulation studies.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |