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Advanced Renal Cell CarcinomaPhase 2NCT00422019

A Phase II Study to Treat Subjects With Advanced Renal Cell Carcinoma

A Phase 2 study testing AMG 102 at 10 mg/kg and AMG 102 at 20 mg/kg 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

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 in patients with Advanced Renal Cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Renal Cell Carcinoma
What is being tested?
AMG 102 at 10 mg/kg and AMG 102 at 20 mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
No sites listed yet
Study dates
Jan 2007to Mar 2009
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • documented histologically confirmed advanced or metastatic renal cell carcinoma with the primary tumor in place or following nephrectomy
  • measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (CT or MRI) or ≥ 10 mm by spiral CT scan
  • no more than 3 relapses (or prior systemic treatments)
  • unable to receive or failed prior therapy with vascular endothelial growth factor (VEGF) binding agents or VEGF receptor tyrosine kinase inhibitors or other multi-kinase inhibitors
  • tissue blocks or tissue sections from initial or upon diagnosis of advanced metastatic disease are available for submission to the central laboratory within approximately 4 weeks after enrollment or approval is granted by the sponsor (upon receipt of justification why the sample is not available)
  • age ≥ 18 years
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  • ECOG performance status of 0-2
  • hemoglobin concentration ≥ 9 g/dL
  • absolute neutrophil count ≥ 1.5 x 10(9th)/L
  • corrected serum calcium ≤ 10 mg/dL
  • either serum creatinine < 2.0 x upper limit of normal OR creatinine clearance > 40 mL/min
  • alanine aminotransferase ≤ 2.5 times upper limit of normal or < 5.0 x ULN if the subject has documented liver metastasis or primary hepatic neoplasm
  • serum total bilirubin ≤ 2.5 times upper limit of normal
  • before any study-specific procedure, the appropriate written informed consent must be obtained

Who cannot join

  • active brain metastases; brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy
  • concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study
  • documented history of human immunodeficiency virus infection
  • documented history of viral chronic hepatitis
  • received biologic, small molecule, immunotherapy, chemotherapy, radiotherapy or other agents to treat renal cancer within 28 days before enrollment
  • treated previously with c-Met or HGF targeted therapy
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  • concurrent or prior (within 7 days before enrollment) anticoagulation therapy, except:
  • Use of low-dose warfarin (< 2 mg/day) for prophylaxis against central venous catheter thrombosis or
  • Use of low molecular weight heparins (LMWH, e.g., enoxaparin sodium [Lovenox] and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed
  • concurrent use of hormones or other chemotherapeutic agents except for steroids given for adrenal failure and hormones administered for non-disease-related conditions (eg, insulin for diabetes); except for non-cancer reasons
  • concurrent palliative or therapeutic radiation therapy
  • currently enrolled in or has not yet completed at least 30 days since ending other investigational device or therapy, or subject is receiving other investigational agent(s)
  • active infection requiring treatment within 1 week before enrollment
  • undergone major surgery within 4 weeks before enrollment or recovering from prior surgery
  • past or current history of another neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative treatment administered for the last 3 years
  • known allergy or sensitivity to any of the excipients in the investigational product to be administered
  • pregnant or is breast feeding
  • not consenting to use adequate contraceptive precautions during the course of the study and for 6 months after the last administration of investigational product:
  • female subjects who are not post-menopausal (no menstrual period for a minimum of 12 months at study entry) or documented surgically sterile will not be bound to this exclusion
  • previously treated with AMG 102
  • previously enrolled into this study
  • will not be available for follow-up assessments
  • has other disorders that compromises the ability of the subject to give written informed consent and/or comply with study procedures
  • unable to begin protocol specified treatment within 3 days after enrollment

About this study

Official title: A Global, Multicenter, Open-label, Single Agent, Two-stage Phase 2 Study to Evaluate the Efficacy and Safety of AMG 102 in Subjects With Advanced Renal Cell Carcinoma

The purpose of this study is to evaluate the effectiveness and safety of AMG 102 in patients with Advanced Renal Cancer.

Being tested
AMG 102 at 10 mg/kg, AMG 102 at 20 mg/kg
Keywords
Renal Cancer, Kidney 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.

  • AMG 102 at 10 mg/kgDrug

    AMG 102 at 10 mg/kg IV (in the vein) every 2 weeks

  • AMG 102 at 20 mg/kgDrug

    AMG 102 at 20 mg/kg IV (in the vein) every 2 weeks

Study groups in NCT00422019
Study groupRoleWhat they receive
AMG 102 at 20 mg/kg Dose LevelExperimentalUp to 40 subjects will be treated at 20 mg/kg of AMG 102 Q2W (every 2 weeks) depending upon the stage of the study and number of responses observed.
Receives: Drug: AMG 102 at 20 mg/kg
AMG 102 at 10 mg/kg Dose LevelExperimentalUp to 40 subjects will be dosed at 10mg/kg of AMG 102 Q2W (every two weeks) based upon the stage of the study and number of responses observed.
Receives: Drug: AMG 102 at 10 mg/kg

What is being measured

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

  1. To assess the objective response rate in subjects with advanced renal cell carcinoma receiving AMG 102 treatment

    Measured: 9 weeks from first dose of AMG 102

Secondary outcomes (4)

  1. To estimate the overall survival and progression free survival rates in this population

    Measured: 8 week intervals

  2. To assess the duration of response and time to response in this population

    Measured: treatment period

  3. To assess the pharmacokinetics of AMG 102 in subjects with advanced renal cell carcinoma

    Measured: Weeks 1, 5, and 9

  4. To assess the safety profile of AMG 102 in subjects with advanced renal cell carcinoma

    Measured: entire study

Timeline

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

  1. First posted15 Jan 2007 (estimated)
  2. Study startJan 2007
  3. Primary completionMar 2009
  4. Study completionMar 2009

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
Parallel groups
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00422019
Sponsor's protocol ID
20060100
Status last verified
Mar 2015
First submitted
11 Jan 2007
Last updated
10 Apr 2015
Results posted
No

Publications

  • Schoffski P, Garcia JA, Stadler WM, Gil T, Jonasch E, Tagawa ST, Smitt M, Yang X, Oliner KS, Anderson A, Zhu M, Kabbinavar F. A phase II study of the efficacy and safety of AMG 102 in patients with metastatic renal cell carcinoma. BJU Int. 2011 Sep;108(5):679-86. doi: 10.1111/j.1464-410X.2010.09947.x. Epub 2010 Dec 13.

    PubMed 21156020

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 102 at 10 mg/kg and AMG 102 at 20 mg/kg 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 14 inclusion and 24 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 10 Apr 2015. 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?

To assess the objective response rate in subjects with advanced renal cell carcinoma receiving AMG 102 treatment (time frame: 9 weeks from first dose of AMG 102). 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 NCT00422019, 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 10 Apr 2015.

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