Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment
NCT ID: NCT00425204
Last Updated: 2008-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2004-03-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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%
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Amgen Inc.
Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Related Links
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Notice regarding posted summaries of trial results
To access clinical trial results information click on this link
FDA-approved Drug Labeling
AmgenTrials clinical trials website
Other Identifiers
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Abgenix Protocol No. ABX-0311
Identifier Type: -
Identifier Source: secondary_id
20020375
Identifier Type: -
Identifier Source: org_study_id
NCT00081185
Identifier Type: -
Identifier Source: nct_alias