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| ID | Type | Description | Link |
|---|---|---|---|
| Abgenix protocol No. ABX-0303 | |||
| Immunex protocol No. 054.0003 |
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Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk in 2 cohorts.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab (ABX-EGF) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2, Cohort 1: Efficacy: Tumor response rate (CR or PR) measured at 8 weeks | ||
| Part 2, Cohort 1: Safety: Incidence and severity of AEs | ||
| Part 2, Cohort 2: Time to disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2, Cohort 1: Time to disease progression | ||
| Part 2, Cohorts 1 & 2: Survival time | ||
| Part 2, Cohorts 1 & 2: PFS |
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Inclusion Criteria:
Able to comprehend and sign an IRB approved Informed Cosent Form
Male or female 18 years of age or older
Female patients who are post menopausal (no menstrual period for a minimum of six months), surgically sterilized, or are using an oral or implanted contraceptive, double barrier birth control, or an IUD and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment into this study
Pathologic diagnosis of renal cell carcinoma by fine needle aspirate or tissue biopsy
Prior nephrectomy
Prior Therapy:
Has bi-dimensionally measurable disease
Has tumor tissue available for diagnostics (acceptable: biopsy, nephrectomy tissue, fine needle aspirate, or archived tissue that is formalin fixed and paraffin embedded). In cases when a fresh biopsy can be obtained, the biopsy should be divided into two; one half should be formalin fixed, and the other half frozen. Tumor samples must be received at the central laboratory prior to patient regisration.
Adequate hematologic data, as follows:
Adequate renal function, as follows:
1. Creatinine < or = 2.2mg/dL
Adequate hepatic function, as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15210739 | Result | Rowinsky EK, Schwartz GH, Gollob JA, Thompson JA, Vogelzang NJ, Figlin R, Bukowski R, Haas N, Lockbaum P, Li YP, Arends R, Foon KA, Schwab G, Dutcher J. Safety, pharmacokinetics, and activity of ABX-EGF, a fully human anti-epidermal growth factor receptor monoclonal antibody in patients with metastatic renal cell cancer. J Clin Oncol. 2004 Aug 1;22(15):3003-15. doi: 10.1200/JCO.2004.11.061. Epub 2004 Jun 21. |
| Label | URL |
|---|---|
| FDA-approved Drug Labeling | View source |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Part 2, Cohorts 1 & 2: Best overall response rate |
| Part 2, Cohorts 1 & 2: Tumor response rate at Weeks 15, 23, 31, and 39 |
| Part 2, Cohorts 1 & 2: Duration of response |
| Part 2, Cohorts 1 & 2: Percent of patients with progressive disease (measured at 8 weeks following initiation of panitumumab treatment) |
| Part 2, Cohorts 1 & 2: Time to CR |
| Part 2, Cohorts 1 & 2: Time to response (PR or CR) |
| AmgenTrials clinical trials website | View source |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |