Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT00803556
Eligibility Criteria:
Inclusion Criteria:
* KPS performance status \>= 70%
* Schedule A: all patients must have a histologically confirmed solid tumor malignancy. Schedule B: patients must have metastatic breast cancer with Her2 amplification by FISH or 3+ Her2 overexpression by immunohistochemistry ("IHC"). Patients are not required to have measurable disease for this investigation. Disease must be assessed within 28 days prior to treatment initiation
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade \<= 2 (except for alopecia)
* The following laboratory results, within 10 days of KOS-1022 administration:
* Hemoglobin \>= 8.5 g/dL
* Absolute neutrophils count \>= 1.5 x 10\*9\* /L
* Platelet count \>= 75 x 10\*9\*/L
* Serum bilirubin \<= 2 x ULN
* AST and ALT \<= 2.5 x ULN
* Serum creatinine \<= 2 x ULN
Exclusion Criteria:
* Documented hypersensitivity reaction of CTCAE Grade \>= 3 to prior therapy containing trastuzumab
* Pregnant or breast-feeding women. Male patients must be surgically sterile or agree to use an acceptable method of contraception
* Known active CNS metastases
* Administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. Patients should be 6 weeks from last dose of nitrosourea
* Patients with Grade 2 or higher dyspnea at rest on room air; patients with other clinically significant pulmonary co-morbidity(s) that might predispose the patient to pulmonary toxicity
* Moderately severe dry eye
* Prior pulmonary toxic chemotherapy (e.g, bleomycin or carmustine)
* Congestive heart failure, or a left ventricular ejection fraction (LVEF)
* Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
* Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin, carcinoma-in-situ of either the uterine cervix or urinary bladder
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00803556
Study Brief:
Protocol Section:
NCT00803556