Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Non-Small Cell Lung Cancer; Prostate Cancer; Solid Tumors; Advanced Renal Cell Carcinoma
• Intervention / Treatment: Drug: Panitumumab (ABX-EGF)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Until disease progression, an AE or withdrawn consent

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the safety of multidose administration of panitumumab in subjects who received continued and extended panitumumab treatment	Until disease progression, an AE or withdrawn consent

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website
• Notice regarding posted summaries of trial results
• FDA-approved Drug Labeling
• To access clinical trial results information click on this link

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: January 18, 2007
• First Submitted That Met QC Criteria: January 18, 2007
• First Posted (Estimate): January 22, 2007

Study Record Updates

• Last Update Posted (Estimate): September 15, 2008
• Last Update Submitted That Met QC Criteria: September 11, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Panitumumab
• Other Study ID Numbers: 20020375; Abgenix Protocol No. ABX-0311