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Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy & Safety of rhuMAb VEGF in Previously Treated Metastatic Renal Cell Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Renal Cell Cancer

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Trial Information

Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy & Safety of rhuMAb VEGF in Previously Treated Metastatic Renal Cell Carcinoma


Inclusion Criteria:



- Written informed consent

- Histologically confirmed, metastatic renal cell cancer (RCC) of clear cell histology

- Clinical or radiographic evidence of disease progression (as assessed by the
investigator and reviewed by the Sponsor) during or after completion of one, and only
one, cytokine-based regimen for metastatic disease

- At least 21 days since any prior therapy for RCC

- Prior nephrectomy

- Use of an acceptable means of contraception (potentially fertile men and women)

- ECOG performance status of 0 or 1

- Life expectancy >= 3 months

- Age 18 years or older

Exclusion Criteria:

- RCC of papillary or collecting-duct type

- More than one nonsurgical therapy for metastatic RCC (note that medroxyprogesterone
acetate not used for physiologic replacement or birth control is considered a therapy
for RCC for the purposes of this study)

- Prior treatment with thalidomide

- Radiotherapy within 14 days of Day 0

- Current, recent (within 21 days of Day 0), or planned participation in an
experimental drug study

- Pregnant or breast-feeding subjects

- Any of the following screening clinical laboratory values: 24-hour urine collection
with >= 1 g of protein; Serum creatinine > 2.0 mg/dL; Absolute neutrophil count (ANC)
<500/mL; Platelet count <75,000/mL; INR >= 1.5; Total bilirubin > 2.0 mg/dL; AST or
ALT > 5 x the upper limit of normal (ULN) for subjects with documented liver
metastases or > 2.5 x the ULN for subjects without evidence of liver metastases;
Hemoglobin < 9 gm/dL (may be transfused or receive epoetin alfa [e.g., Epogen] to
maintain or exceed this level)

- Other invasive malignancies within 5 years of randomization (other than squamous or
basal cell carcinoma of the skin)

- History of other disease, 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 might affect the
interpretation of the results of the study or render the subject at high risk from
treatment complications

- Inability to comply with study and/or follow-up procedures

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

AVF2665g

NCT ID:

NCT00061178

Start Date:

Completion Date:

Related Keywords:

  • Renal Cell Cancer
  • Carcinoma
  • Carcinoma, Renal Cell

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