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Advanced Renal Cell CarcinomaPhase 2NCT00425035

Safety and Efficacy Study of ABX-EGF in Patients With Renal Cancer, Part 2

A Phase 2 study testing Panitumumab (ABX-EGF) in people with Advanced Renal Cell Carcinoma, run by Amgen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk in 2 cohorts. Read more about this study

Who is it for?
Any age
Conditions the study is for
Advanced Renal Cell Carcinoma
What is being tested?
Panitumumab (ABX-EGF)
How many people
115 participants
Where
No sites listed yet
Study dates
Feb 2003to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Child, Adult, Older adult

Who may be able to join

  • Able to comprehend and sign an IRB approved Informed Cosent 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 IUD and have a negative serum pregnancy test upon entry into this study; or male patients willing to use contraception upon enrollment into this study
  • Pathologic diagnosis of renal cell carcinoma by fine needle aspirate or tissue biopsy
  • Prior nephrectomy
  • Prior Therapy:
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  • Cohort 1 only: Previously received and failed one prior biotherapy, defined as IL-2 therapy or interferon-alpha (alone or in combination); Karnosky score of > or = 70%
  • Cohort 2 only: No prior therapy except nephrectomy and fall within the Motzer intermediate group with one or two of the risk factors, as defined in teh Study Design section.
  • Has bi-dimensionally measurable disease
  • Has tumor tissue available for diagnostics (acceptable: biopsy, nephrectomy tissue, fine needle aspirate, or archived tissue that is formalin fixed and paraffin embedded). In cases when a fresh biopsy can be obtained, the biopsy should be divided into two; one half should be formalin fixed, and the other half frozen. Tumor samples must be received at the central laboratory prior to patient regisration.
  • Adequate hematologic data, as follows:
  • ANC > 1.5 x 109/L
  • Platelet count > 100x 109/L
  • Adequate renal function, as follows:
  • 1. Creatinine < or = 2.2mg/dL
  • Adequate hepatic function, as follows:
  • Alkaline phosphatase < or = 3x ULN
  • AST < or = 3x ULN
  • ALT < or = 3x ULN
  • Total bilirubin < or = 1.5x ULN

Who cannot join

  • Brain metastases
  • Cohort 1 only: Hypercalcemia (calcium level outside the upper limit of normal; antihypercalcemic treatment is allowed)
  • Cancer therapy within 30 days of ABX-EGF infusion (hormone therapy is allowed; steroid therapy is only allowed if it is replacement therapy)
  • Use of any investigational drug within 30 days of ABX-EGF infusion
  • Prior treatment with any anti-EGFr agents
  • Left ventricular ejection fraction < 45%, as measured by MUGA Scan
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  • Myocardial infarction within one year prior to entering the study
  • Has other cancer that has been active and required treatment within the past 5 years (prior renal cell carcinoma, basal cell carcinoma, or cervical carcinoma in situ are allowed)
  • Pregnant or breast feeding female; male or 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 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 participation or study drug administration or may interfere with the interpretation of study results
  • Allergy to the ingredients of the study medication or to Staphylococcus Protein A

About this study

Official title: A Two-part, Multiple Dose Clinical Trial Evaluating the Safety and Effectiveness of ABX-EGF in Patients With Renal Carcinoma

Multicenter, 2-part, multiple-dose study designed to evaluate the safety and effectiveness of weekly administration of panitumumab in subjects with renal carcinoma. Part 1 was initiated in 2001 and will not be presented here. Part 2 was designed to examine a dose of 2.5 mg/kg/wk in 2 cohorts.

Being tested
Panitumumab (ABX-EGF)
Keywords
Renal Cancer
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Panitumumab (ABX-EGF)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 2, Cohort 1: Efficacy: Tumor response rate (CR or PR) measured at 8 weeks

  2. Part 2, Cohort 1: Safety: Incidence and severity of AEs

  3. Part 2, Cohort 2: Time to disease progression

Secondary outcomes (9)

  1. Part 2, Cohort 1: Time to disease progression

  2. Part 2, Cohorts 1 & 2: Survival time

  3. Part 2, Cohorts 1 & 2: PFS

  4. Part 2, Cohorts 1 & 2: Best overall response rate

  5. Part 2, Cohorts 1 & 2: Tumor response rate at Weeks 15, 23, 31, and 39

  6. Part 2, Cohorts 1 & 2: Duration of response

  7. Part 2, Cohorts 1 & 2: Percent of patients with progressive disease (measured at 8 weeks following initiation of panitumumab treatment)

  8. Part 2, Cohorts 1 & 2: Time to CR

  9. Part 2, Cohorts 1 & 2: Time to response (PR or CR)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2007 (estimated)
  2. Study startFeb 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425035
Sponsor's protocol ID
20020374
Other IDs
Abgenix protocol No. ABX-0303, Immunex protocol No. 054.0003
Status last verified
May 2013
First submitted
18 Jan 2007
Last updated
13 May 2013
Results posted
No

Publications

  • Rowinsky EK, Schwartz GH, Gollob JA, Thompson JA, Vogelzang NJ, Figlin R, Bukowski R, Haas N, Lockbaum P, Li YP, Arends R, Foon KA, Schwab G, Dutcher J. Safety, pharmacokinetics, and activity of ABX-EGF, a fully human anti-epidermal growth factor receptor monoclonal antibody in patients with metastatic renal cell cancer. J Clin Oncol. 2004 Aug 1;22(15):3003-15. doi: 10.1200/JCO.2004.11.061. Epub 2004 Jun 21.

    PubMed 15210739

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Panitumumab (ABX-EGF) in people with Advanced Renal Cell Carcinoma, run by Amgen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 2, Cohort 1: Efficacy: Tumor response rate (CR or PR) measured at 8 weeks. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00425035, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.

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