Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel in Patients With Advanced Solid Tumor Malignancies or Her2 Positive Metastatic Breast Cancer Who Have Previously Failed Trastuzumab Therapy
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Keep this study
Lead
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel in Patients With Advanced Solid Tumor Malignancies or Her2 Positive Metastatic Breast Cancer Who Have Previously Failed Trastuzumab Therapy
