E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patiens with confirmed metastatic breast or colorectal cancer. Breast:Pats should have received/failed at least 1 but no more than 2 lines of chemotherapy with taxanes and/or anthracyclines for metastatic disease. Colorectal:Pats not eligible for 1. chemotherapy of 5-FU with either oxaliplatin/irinotecan/bevacizumab. Pats are eligible if having received 1.line chemotherapy of 5-FU with either oxaliplatin/irinotecan/bevacizumab, but unable to tolerate >2 cycl. due to treatment-related toxicity |
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MedDRA Classification |
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 determine the objective tumour response rate (complete and partial response of target lesions) in patients diagnosed with advanced breast or colorectal cancer after three complete cycles of treatment with fosfluridine tidoxil |
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E.2.2 | Secondary objectives of the trial |
To determine the objective tumour response rate (complete response of non-target lesions as determined in accordance with the Response Evaluation Criteria in Solid Tumours (RECIST) criteria) in patients diagnosed with advanced breast or colorectal cancer, after three complete cycles of treatment with fosfluridine tidoxil. To determine the time to the best overall tumour response (target and non-target lesions). To determine the duration of overall tumour response. To determine the time to disease progression. To determine the change in Eastern Cooperative Oncology Group (ECOG) performance status. To determine the pharmacokinetics (PK) of Fosfluridine Tidoxil. To assess the safety and tolerability of the treatment regimen by evaluating laboratory tests (haematology, clinical chemistry and urinalysis [dipstick]), vital signs, 12-lead electrocardiogram (ECG) and adverse events in patients treated with fosfluridine tidoxil. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Patients with histologically or cytologically confirmed metastatic breast or colorectal cancer. - At least one measurable lesion, as identified within the 4-week period prior to Screening (Visit 1 [Day -3 to -1]), which has not previously been irradiated. Minimum measurable lesion size, in accordance with the RECIST criteria as measured at Screening (Visit 1 [Day -3 to -1]) or within the prior 4-week period :>= 10 mm measured by spiral computed tomography (CT) scan, or >= 20 mm measured by conventional CT scan. - Male or female patients aged 18 years or older. - Predicted life expectancy of >= 12 weeks as determined at Screening (Visit 1 [Day -3 to -1]), allowing adequate follow-up evaluation for toxicity and tumour response. - Performance status of <= 2 on the ECOG scale |
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E.4 | Principal exclusion criteria |
- Patients who received radiotherapy of one or more of the target lesions, within the 4 -week period prior to Screening (Visit 1 [Day 3 to -1]). - Patients who are scheduled to receive planned radiotherapy during the planned Treatment Period or during follow-up. - Patients who received more than 2 cycles of a 5-FU-containing combination chemotherapy in the treatment of metastatic colorectal cancer. - Patients who have received 5-fluoropyrimidine-containing adjuvant treatment for colorectal cancer that was completed less than 12 months prior to Screening (Visit 1 [Day -3 to -1]). - Patients who received more than two lines chemotherapy containing taxanes and/or anthracyclines in the treatment of metastatic breast cancer. - Patients who have received neoadjuvant or adjuvant treatment for breast cancer that was completed less than 12 months prior to Screening (Visit 1 [Day -3 to -1]). - Patients who received major surgery within the 4-week period prior to the first administration of study drug (Cycle 1 [Day 1]). - Patients who received major surgery more than 4 weeks prior to the first administration of study drug (Cycle 1 [Day 1]), but who did not completely recover after surgery. - Patients who received minor surgery within the 2-week period prior to the first administration of study drug (Cycle 1 [Day 1]). - Patients who received radiotherapy or chemotherapy within the 4-week period prior to the first administration of study drug (Cycle 1 [Day 1]). - Patients who received autologeous or allogeneic bone marrow transplantation at any time prior to Screening (Visit 1 [Day -3 to -1]). Patients with known brain or meningeal metastases as determined at Screening (Visit 1 [Day -3 to -1]). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Objective tumour response rate on target lesions.
At least one, but not more than ten target lesions, as identified prior to the first administration of study drug will be measured and the sum of the longest diameter of target lesions will be calculated. The percentage change in the sum of the longest diameter of the target lesions will be calculated |
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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 | Yes |
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 | 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) | 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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |