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
Conditions
Interventions
Product Name: Fosfluridine Tidoxil
Product Code: HDP 99.0006
Pharmaceutical Form: Capsule*
INN or Proposed INN: Fosfluridine tidoxil
CAS Number: RN174638-187
Current Sponsor code: HDP 99.0006
Concentr
Sponsors
Heidelberg Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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]).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 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.;Main Objective: 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;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 | — |
Countries
Austria
Outcome results
None listed