Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors

Amgen

Status and phase: Completed; Phase 1

Conditions: Tumors; Oncology; Solid Tumors

Treatments: Drug: Panitumumab; Drug: panitumumab (ABX-EGF)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091806

20030251

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and pharmacokinetics of two dose schedules of panitumumab in subjects with advanced solid tumors.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Pathologic diagnosis of advanced solid tumors that are refractory to at least 1 standard therapy or for which no standard therapy is available and have not received more than 3 prior treatment regimens (not inclusive of hormonal therapies for breast and prostate cancer subjects) for the advanced solid tumor (tumor must be diagnosed by standard criteria for the specific tumor type)

• Measurable disease or evaluable (non-measurable) disease per RECIST guidelines (all sites of disease must be evaluated within 28 days before enrollment)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy of > 3 months as documented by the investigator

• If history of other primary cancer, subject will be eligible only if she or he has:

  • Non-melanomatous skin cancer, not requiring treatment
  • Curatively treated cervical carcinoma in situ
  • Other primary solid tumor curatively treated with no known active disease present for the last 5 years and no treatment administered for the last 3 years

• Man or woman 18 years of age or older

• Paraffin-embedded tumor tissue (from primary or metastatic tumor tissue) available for immunohistochemistry studies of EGFr expression (biopsy or archived tissue are acceptable). The immunohistochemical EGFr staining and evaluation must be conducted at the designated central laboratory using the DakoCytomation EGFR pharmDXTM kit. Local laboratory EGFr expression is not permitted for the purpose of eligibility in this study

• Hematologic function, as follows:

  • Absolute neutrophil count (ANC) > 1.5 x 109/L
  • Platelet count > 100 x 109/L
  • Hemoglobin > 8 g/dL

• Renal function, as follows:

  o Creatinine < 2.0 mg/dL

• Hepatic function, as follows:

  • Aspartate aminotransferase (AST) < 3 x ULN (if liver metastases ≤ 5 x ULN)
  • Alanine aminotransferase (ALT) < 3 x ULN (if liver metastases ≤ 5 x ULN)
  • Bilirubin < 2 x ULN

• Competent to comprehend, sign, and date an IEC/IRB-approved informed consent form

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Cohort 1

Experimental group

Description:

6mg/kg of panitumumab administered once every 2 weeks until subjects develop disease progression or are unable to tolerate the study drug

Treatment:

Drug: panitumumab (ABX-EGF)

Cohort 2

Experimental group

Description:

Panitumumab 9 mg/kg administered once every 3 weeks until subjects develop disease progression or are unable to tolerate the study drug.

Treatment:

Drug: Panitumumab