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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 October 2014 |
Main ID: |
EUCTR2006-002221-23-BE |
Date of registration:
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25/10/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients
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Scientific title:
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An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients |
Date of first enrolment:
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28/12/2006 |
Target sample size:
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135 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002221-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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France
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Germany
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically proven triple-receptor-negative metastatic or relapsed breast cancer 2. Minimum interval of 6 months after the end of any previous taxane-containing chemotherapy regimen 3. At least one tumor lesion measurable according to RECIST criteria 4. Gender: female 5. Age equal or mayor 18 years old 6. Negative pregnancy test (females of childbearing potential) 7. Willingness to perform double-barrier-contraception during studyand for 6 months post chemotherapy treatment 8. ECOG performance status 0, 1 or 2 9. Signed informed consent 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: 1. More than 1 previous chemotherapeutic treatment for metastatic or relapsed disease 2. Major surgery < 4 weeks prior to enrollment 3. Immunotherapy < 2 weeks prior to enrollment 4. Severe pulmonary obstructive or restrictive disease 5. Uncontrolled inflammatory disease (autoimmune or infectious) 6. Clinically significant cardiac disease (NYHA stadium > 2) 7. Laboratory tests (hematology, chemistry) outside specified limits: • WBC < 3 x 109/L • ANC = 1.5 x 109/L • Platelets = 100 x 109/L • Hb = 9.0 g/dl (= 5.6 mmol/l) • PTT/ INR > 1.5 x ULN • AST or ALT > 2.5 x ULN • Alkaline Phosphatase > 2 x ULN • Total Bilirubin > 1.5 x ULN 8. Pregnancy or nursing status 9. Known positive HIV testing 10. Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations 11. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally 12. Known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study) 13. History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial 14. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Patients with triple negative breast cancer MedDRA version: 8.1
Level: LLT
Classification code 10027475
Term: Metastatic breast cancer
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Intervention(s)
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Product Name: EndoTAG-1 (Liposomal paclitaxel) Product Code: MDG 09.101 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Paclitaxel Current Sponsor code: MDG 09.100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6.40-
Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069-62-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
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Primary Outcome(s)
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Secondary Objective: Secondary objective is to assess the safety and tolerability of EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in this patient population.
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Main Objective: Primary objective is to assess the efficacy of EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) as a rescue therapy for patients with triple receptor negative relapsed and/or metastatic breast cancer.
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Primary end point(s): Primary efficacy endpoint is: 4-month progression free survival (PFS) rate calculated by the rate of patients in the modified intention-to-treat population (mITT) who show no progression of disease and are alive 16 weeks after first infusion of study drug.
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Source(s) of Monetary Support
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Results
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Results available:
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