Clinical trial NCT00091806: Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
Official title: An Open-Label, Clinical Trial Evaluating the Safety and Pharmacokinetics of Two Dose Schedules of Panitumumab in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Oncology
Solid Tumors
Keywords: Targeted Therapy
Solid tumors
ABX-EGF, panitumumab
EGFr
Immunex, Abgenix, Amgen
Monoclonal Antibody
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2004-09-21
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: To evaluate the safety and PK of 2 dose schedules of panitumumab in subjects with advanced solid tumors, refractory to or with no available standard therapy.
timeFrame: 2 years
Secondary outcomes:
measure: To asses the immunogenicity and efficacy of 2 dose schedules of panitumumab in subjects with advanced solid tumors.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Stephenson JJ, Gregory C, Burris H, Larson T, Verma U, Cohn A, Crawford J, Cohen RB, Martin J, Lum P, Yang X, Amado RG. An open-label clinical trial evaluating safety and pharmacokinetics of two dosing schedules of panitumumab in patients with solid tumors. Clin Colorectal Cancer. 2009 Jan;8(1):29-37. doi: 10.3816/CCC.2009.n.005.