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CompletedNCT00425204Updated Sep 15, 2008

Study for Patients Who Have Benefited and Tolerated Prior Panitumumab Treatment

A Phase 2 interventional study of Panitumumab (ABX-EGF) in Colorectal Cancer, Non-Small Cell Lung Cancer and Prostate Cancer, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-09-15.

Sponsored by Amgen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Colorectal Cancer
  • Non-Small Cell Lung Cancer
  • Prostate Cancer
  • Solid Tumors
  • Advanced Renal Cell Carcinoma
03

In context

Carcinoma, Renal Cell

1,965 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.

This study's enrollment of 31 is below the median of 42 across 1,480 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • 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)

Interventions

  • DrugPanitumumab (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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00425204
Lead sponsor
Amgen
First posted
Jan 22, 2007
Start date
Mar 2004
Primary completion
Sep 2007
Completion
Mar 2008
Last update
Sep 15, 2008

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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