Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00425204

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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

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

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Mar 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

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treatment in Studies 20020374 Part 2 or 20030138 and its extension study, 20040116 [Until disease progression, an AE or withdrawn consent]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Amgen

Investigators

Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00425204

Other Study ID Numbers:

20020375
Abgenix Protocol No. ABX-0311
NCT00081185

First Posted:

Jan 22, 2007

Last Update Posted:

Sep 15, 2008

Last Verified:

Sep 1, 2008

Additional relevant MeSH terms:

Carcinoma, Renal Cell

Panitumumab

Study Results

No Results Posted as of Sep 15, 2008