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A Phase I, Open-Label, Multicenter, Dose-Escalation Study of the Safety and Pharmacokinetics of a Recombinant Humanized Antibody to Her2 (rhuMAb 2C4) Administered Every 3 Weeks to Subjects With Advanced Solid Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

A Phase I, Open-Label, Multicenter, Dose-Escalation Study of the Safety and Pharmacokinetics of a Recombinant Humanized Antibody to Her2 (rhuMAb 2C4) Administered Every 3 Weeks to Subjects With Advanced Solid Malignancies


Inclusion Criteria:



- Signed informed consent

- Age >=18 years old

- ECOG performance status of 0 or 1 (see Appendix F)

- Life expectancy of >=12 weeks

- Histologically documented, incurable, locally advanced or metastatic solid
malignancies

- Disease progression on or after standard effective therapy or a malignancy for which
there is no standard therapy

- At least one bi-dimensionally measurable lesion (>=2 cm [>=1 cm on spiral CT scan])

- HER2-negative status as defined by fluorescence in situ hybridization (FISH) testing
(only for subjects with breast cancer)

- Use of an effective means of contraception for women of childbearing potential

- Granulocyte count of >=1500/uL, platelet count of >=100,000/uL, and hemoglobin of >=9
g/dL

- Serum bilirubin less than or equal to the upper limit of normal (ULN) and alkaline
phosphatase, AST, and ALT <=2.5x ULN (ALT and AST <=5x ULN for subjects with liver
metastases; alkaline phosphatase <=5x ULN for subjects with liver or bone metastases)

- Serum creatinine less than or equal to ULN or creatinine clearance of >=60 mL/min

- International normalized ratio (INR) of <1.3 and activated partial thromboplastin
time (aPTT) of <1.5x ULN

Exclusion Criteria:

- Pleural effusions, ascites, or bone lesions as the only manifestation of the current
cancer

- Symptomatic or untreated brain metastases

- Prior chemotherapy, hormonal therapy (except for androgen-deprivation therapy for
subjects with prostate cancer), radiotherapy, or immunotherapy within 4 weeks of Day
1 (within 6 weeks for nitrosoureas or mitomycin)

- Prior treatment with Herceptin

- Prior cumulative doxorubicin dose of >360 mg/m2 or the equivalent

- History of other malignancies within 5 years of Day 1 except for adequately treated
carcinoma in situ of the cervix or basal or squamous cell skin cancer

- History of significant cardiac disease, unstable angina, congestive heart failure,
myocardial infarction, or ventricular arrhythmia requiring medication

- Ejection fraction of <50% or below the lower limit of normal determined by ECHO
(Subjects who are unable to have ejection fraction evaluated by ECHO may have
ejection fraction evaluated by a MUGA scan, although this must be discussed with the
Medical Monitor prior to enrollment.)

- Active infection requiring IV antibiotics

- Uncontrolled hypercalcemia (>11.5 mg/dL)

- Clinically important history of liver disease, including viral or other hepatitis,
current alcohol abuse, or cirrhosis

- Known human immunodeficiency virus (HIV) infection

- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the subject at high risk from treatment
complications

- Major surgery or significant traumatic injury within 3 weeks of Day 1

- Pregnancy or lactation

- Inability to comply with study and follow-up procedures

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

TOC2297g

NCT ID:

NCT00027027

Start Date:

November 2001

Completion Date:

Related Keywords:

  • Neoplasms
  • Neoplasms

Name

Location

Cedars-Sinai Medical CenterLos Angeles, California  90048