E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ovarian carcinoma (FIGO stage IIIA and IIIB/IIIC/IV; patients with extra-abdominal disease will be excluded by the study unless those with pleural effusion) with minimal/microscopic residual disease. |
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E.1.1.1 | Medical condition in easily understood language |
Ovarian carcinoma (FIGO stage IIIA and IIIB/IIIC/IV) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the efficacy of repeated intraperitoneal administrations of TALL-104 in patients affected by ovarian carcinoma. |
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E.2.2 | Secondary objectives of the trial |
Evaluate:
-safety of TALL-104 after repeated intraperitoneal administration;
-kinetics of TALL-104 cells in peripheral blood by PCR or karyotyping;
-immunological monitoring (human autologous anti-TALL-104 antibodies, anti-BSA antibodies and cellular response against TALL-104 cells);
-tumour markers.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Diagnosis of ovarian carcinoma FIGO stage IIIA and IIIB/IIIC/IV
-Patients not eligible for treatment with Bevacizumab
-Minimal or microscopic residual disease at second look laparotomy/laparoscopy (patients with extra-abdominal disease will be excluded by the study unless those with pleural effusion). Microscopic residual disease is defined as positive cytology washing and/or positive random biopsies at 2nd look, while minimal residual disease is defined as tumour lesion/lesions of diameter < 0.5 cm at 2nd look.
-Written Informed Consent.
-Patients will be selected as follows:
-Patients who signed the Informed Consent Form and considered eligible to 2nd look laparoscopy because have no clinical evidence of disease (negative CT scan and negative pelvic exam) during the screening phase.
-Patients who underwent 2nd laparotomy and who accept to provide signed Informed Consent Form to use the collected histology/cytology samples.
-Age 18 to 75 years.
-P.S.: 2 (WHO scale).
-First line treatment including Platinum compounds and Paclitaxel.
-Second look laparotomy/laparoscopy performed not more than 8 weeks before day 1.
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E.4 | Principal exclusion criteria |
1. Evidence of extraperitoneal metastatic disease.
2. Clinically significant cardiovascular, hepatic, gastrointestinal, haematological or psychiatric diseases as judged by the Investigator.
3. HIV infection.
4. Medical conditions requiring steroid administration.
5. Chemotherapy within the previous four weeks.
6. Serum Creatinine > 1.5 mg/dl.
7. Absolute neutrophil count < 1,500/mm3 and platelets < 100,000/mm3 .
8. Use of other investigational drugs/treatments, or enrolment in a clinical study within the previous 3 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the conversion rate from minimal/microscopic residual disease to pathological complete response. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Pathological complete response evaluated at third look laparoscopy |
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E.5.2 | Secondary end point(s) |
To evaluate:
-safety of TALL-104 after repeated intraperitoneal administration;
-kinetics of TALL-104 cells in peripheral blood by PCR or karyotyping;
-immunological monitoring (human autologous anti-TALL-104 antibodies, anti-BSA antibodies and cellular response against TALL-104 cells);
-tumour markers
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. safety: from the screening visit (Visit 0) to the last Follow up visit.
2. kinetics: from Visit 1 to Visit 15 of each course of treatment.
3. immunological monitoring: from Visit 1 to the last Follow up visit.
4. tumour markers evaluation: from Visit 1 to the last Follow up visit. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
1. Immunological monitoring.
2. Tumour markers evaluation. |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
At two stages (Simon's design: 18 evaluable patients at first step and 17 at second step) |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |