Breast Cancer
Conditions
Sponsors
Xanthus Pharmaceuticals Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must fulfill all of the following criteria to be eligible for study selection: a.) Women 18 years or older; b.) Histologically or cytologically confirmed breast cancer; c.) Metastatic breast cancer; d.) Subjects who relapsed within 12 months after completion of adjuvant or neoadjuvant therapy containing an anthracycline and a taxane or who have received at least one prior therapy for the treatment of metastatic disease. e.) Subjects must have received prior therapy with an anthracycline in either the adjuvant or metastatic setting; f.) Subjects must have received prior therapy with an taxane in either the adjuvant or metastatic setting; g.) Subjects may have been treated with hormonal and/or targeted therapies (such as trastuzumab), but such therapy must have been terminated prior to signing of the informed consent; h.) Prior chemotherapy treatment must have been terminated at least 3 weeks before the first administration of Symadex (C-1311); i.) Measurable disease according to RECIST criteria by radiographic methods (CT scan or MRI) and/or clinical examination; j.) ECOG Performance score less than or equal to 2 with an expected survival of at least 12 weeks; k.) Adequate renal function as evidenced by the following laboratory tests: Serum creatinine less than or equal to 1.5 x ULN; l.) Adequate hepatic function as evidenced by the following laboratory tests: Serum bilirubin less than or equal to 1.5 x ULN; Alkaline phosphatase less than or equal to 2.5 x ULN (less than or equal to 5 x ULN, in case of liver metastases); Serum AST or ALT less than or equal to 2.5 x ULN (less than or equal to 5 x ULN, in case of liver metastases); m.) Adequate hematologic status as evidenced by the following laboratory tests: Total WBC greater than or equal to 3.0 x 10^9/L (3,000/mm^3); Neutrophils greater than or equal to 1.5 x 10^9/L (1,500/mm^3); Platelets greater than or equal to 100 x 10^9/L (100,000/mm^3); Hemoglobin greater than or equal to 9.0 g/dL (9g/100 mL); n.) Negative pregnancy test (urine or blood) and an effective contraception method in women of childbearing potential. Reliable contraception must have been started 4 weeks prior to signing of the informed consent form and must be continued throughout the study and until at least four weeks after completion of study treatment. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives; o.) Previous radiotherapy is allowed if the end of the treatment was more than 4 weeks prior to the first administration of Symadex (C-1311). Acute radiation toxicities must have resolved. Tumor lesions which are situated in a previously irradiated field will not be considered measurable, unless radiation therapy was completed at least 6 months prior to obtaining screening measurements and the lesion(s) has/have appeared or increased in size since that radiation therapy; p.) Expected co-operation of the subject for the treatment and follow-up must
Exclusion criteria
Exclusion criteria: Subjects must not meet any of the following criteria to be eligible for study selection: a.) Myocardial infarction within 3 months of signature of the informed consent; b.) Unstable angina pectoris, cardiac insufficiency (NYHA Class III-IV), uncontrolled arrhythmia, or uncontrolled hypertension at the time of signature of the consent form; c.) Left Ventricular Ejection Fraction (LVEF) 450 msec; e.) Pre-existing neuropathy (motor or sensory) > grade 2; f.) Clinically significant abnormal hematological parameters other than those defined in the inclusion criteria; g.) Clinically significant abnormal biochemical parameters other than those defined in the inclusion criteria; h.) Known history or presence of brain or leptomeningeal metastases; i.) Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease; j.) Prior major surgery less than 4 weeks before the first administration of Symadex (C-1311). Subject must have recovered from prior surgery; k.) Subjects who received treatment with myeloid growth factors (i.e. G-CSF, GM-CSF) or blood transfusion within 2 weeks of obtaining the screening hematological blood work; l.) Pregnant or lactating women; m.) Clinically significant active infections; n.) Other prior malignancies, except for cured non melanoma skin cancer or curatively treated in situ carcinoma of the cervix or adequately treated malignancies for which there has been no evidence of activity for more than 5 years; o.) Other serious illness or medical condition; p.) Subjects with a history of a mental illness or condition which may interfere with the subjects’ ability to understand the requirements of the study; q.) Subjects who received an investigational new drug within 4 weeks of the first administration of Symadex (C-1311); r.) Any other known condition which in the investigator’s opinion would not make the subject a good candidate for the trial; s.) Known HIV positive or active hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective: - Evaluate the overall response rate (CR+PR) using RECIST criteria. ; Secondary Objective: - Determine the toxicity profile of Symadex (C-1311); - Determine the time to progression (TTP); - Determine duration of response; - Define the pharmacokinetic and metabolic clearance profile of Symadex (C-1311). ; Primary end point(s): Primary: Overall response rate (ORR) (complete response (CR) + partial response (PR)) using RECIST criteria. Secondary:Time to progression (TTP), duration of response. | — |
Countries
United Kingdom
Outcome results
None listed