Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00425204
First received: January 18, 2007
Last updated: September 11, 2008
Last verified: September 2008
  Purpose

A multi-center, open-label, extended treatment, clinical trial examining the safety of administering multiple does of panitumumab by intravenous (i.v.) infusion to patients who have previously received panitumumab and benefited from treatment


Condition Intervention Phase
Colorectal Cancer
Non-Small Cell Lung Cancer
Prostate Cancer
Solid Tumors
Advanced Renal Cell Carcinoma
Drug: Panitumumab (ABX-EGF)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label Clinical Trial To Determine The Safety of ABX-EGF As Continued Treatment For Patients Who Have Benefited From and Tolerated Prior ABX-EGF Treatment

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To provide continued, extended panitumumab treatment to subjects who appeared to have benefited from and tolerated previous panitumumab treatment in Studies 20020374 Part 2 or 20030138 and its extension study, 20040116 [ Time Frame: Until disease progression, an AE or withdrawn consent ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the safety of multidose administration of panitumumab in subjects who received continued and extended panitumumab treatment [ Time Frame: Until disease progression, an AE or withdrawn consent ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: March 2004
Study Completion Date: March 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label
Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks.
Drug: Panitumumab (ABX-EGF)
Dose received in previous studies will be rolled over to this study. These regimens include: 2.5 mg/kg weekly; 6.0 mg/kg every 2 weeks; and 9.0 mg/kg every 3 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to comprehend and sign an IRB approved Informed Consent 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 intrauterine device (IUD) and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment and during the course of the study
  • Previously received and tolerated panitumumab treatment on studies 20020374 Part 2 or 20030138/20040116
  • Is considered "stable" or "responding" based on the RECIST (20020374 Part 2) or WHO (20040116) criteria, at the final treatment visit of the previous panitumumab clinical trial and the screening visit for this study
  • No more than 2 months (60 days) have elapsed since the final treatment visit of the previous panitumumab clinical trial
  • Karnofsky score > or = 70%

Exclusion Criteria:

  • Brain metastases (20040116 patients are allowed only if controlled and asymptomatic)
  • Uncontrolled hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed). Exception: Patients in the Motzer Intermediate Risk Group from 20020374 Cohort 2 with uncontrolled high corrected calcium (>10 mg/dl) may be enrolled
  • Use of any anti-tumor therapy or investigational drug, other than panitumumab, between the last visit of the previous panitumumab study and the initial visit in this 20020375 study
  • Prior treatment with another anti-EGFr agent, other than panitumumab
  • Myocardial infarction within 1 year prior to entering the study
  • Has other cancer that has been active and required treatment within the past 5 years (basal cell carcinoma or cervical carcinoma in situ are allowed)
  • Pregnant or breast feeding female; female of childbearing potential (defined as: post menarche and is biologically capable of becoming pregnant) unwilling to use birth control (as defined in the inclusion criteria) during and for 6 months following treatment
  • Male patient unwilling to use birth control (as defined in the inclusion criteria) during and for 1 month following treatment
  • Known to be HIV positive
  • History of any chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risks associated with study drug administration
  • Allergy to the ingredients of the study medication or to Staphylococcus Protein A
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425204

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00425204     History of Changes
Obsolete Identifiers: NCT00081185
Other Study ID Numbers: 20020375, Abgenix Protocol No. ABX-0311
Study First Received: January 18, 2007
Last Updated: September 11, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Colorectal Neoplasms
Prostatic Neoplasms
Adenocarcinoma
Bronchial Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Intestinal Diseases
Intestinal Neoplasms
Kidney Diseases
Kidney Neoplasms
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Rectal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 30, 2014