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

Amgen0 sites31 target enrollmentMarch 2004

ConditionsColorectal Cancer Non-Small Cell Lung Cancer Prostate Cancer Solid Tumors Advanced Renal Cell Carcinoma

InterventionsPanitumumab (ABX-EGF)

DrugsPanitumumab (ABX-EGF)

Overview

Phase: Phase 2
Intervention: Panitumumab (ABX-EGF)
Conditions: Colorectal Cancer
Sponsor: Amgen
Enrollment: 31
Primary Endpoint: 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
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

March 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amgen

Eligibility 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

Arms & Interventions

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.

Intervention: Panitumumab (ABX-EGF)

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)