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Phase 1 Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel

Phase 1
18 Years
Not Enrolling
Solid Tumor, Breast Cancer

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Trial Information

Phase 1 Clinical Trial of the Combination of Intravenous Alvespimycin (KOS-1022), Trastuzumab With or Without Paclitaxel

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Dose Limiting Toxicities

Outcome Time Frame:

During Cycle 1 (4-weeks in duration)

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

August 2009

Related Keywords:

  • Solid Tumor
  • Breast Cancer
  • Breast Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, Indiana  46202