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Bone Metastases in Men With Hormone-Refractory Prostate CancerPhase 2NCT00104650

Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous (IV) Bisphosphonates

A Phase 2 study testing AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks and AMG 162- 180 mg q 4 weeks in people with Bone Metastases in Men With Hormone-Refractory Prostate Cancer and Bone Metastases in Subjects With Advanced Breast Cancer, 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 trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks and AMG 162- 180 mg q 4 weeks
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
No sites listed yet
Study dates
Jan 2005to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma
  • Radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma
  • Currently receiving IV bisphosphonates
  • Urinary N-Telopeptide (uNTx) greater than 50 nM BCE/mM creatinine
  • Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

Who cannot join

  • More than 2 prior skeletal related events (SRE)
  • Known brain metastases
  • Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
  • Active dental or jaw conditions which requires oral surgery
  • Non-healed dental/oral surgery
  • Prior administration of AMG 162
  • Evidence of impending fracture in weight bearing bones
  • Pregnancy or breastfeeding. Subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the study.

About this study

Official title: A Randomized, Open Label, Active Controlled Study of AMG 162 in Subjects With Advanced Cancer Currently Being Treated With Intravenous Bisphosphonates

The purpose of this trial is to determine the effectiveness of AMG 162 in reducing urinary N-telopeptide in advanced cancer subjects with bone metastases.

Being tested
AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks, AMG 162- 180 mg q 4 weeks
Keywords
Bone Metastases, AMG 162, Bisphosphonates, Solid Tumor Carcinomas, Advanced
Medical subject headings
Multiple Myeloma

What participants receive

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

  • AMG 162 180 mg (SC) q 12 weeksGenetic

    A 180 mg AMG 162 (SC) administered every 12 weeks for 2 doses (Day 1 and wk 13) in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 12 weeks for 9 doses.

  • IV Bisphosphonate q 4 weeksDrug

    IV Bisphosphonate (eg pamidronate or zoledronic acid) every 4 weeks for 6 doses as described by package insert during the treatment phase. If enrolled to the extension phase, subject will be assigned to the AMG 162 180mg (SC) every 4 weeks for 26 doses.

  • AMG 162- 180 mg q 4 weeksGenetic

    A 180 mg AMG 162 (SC) administered every 4 weeks for 6 doses in the treatment phase. If subjected are enrolled in the extension phase, they will continue to receive a 180 mg AMG 162 (SC) administered every 4 weeks for 26 doses.

Study groups in NCT00104650
Study groupRoleWhat they receive
IV Bisphosphonates q 4 weeksActive comparatorThis is an open-label randomization to receive IV bisphosphonate (administered per package insert) every 4 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will receive AMG 162 180mg (SC) every 4 weeks.
Receives: Drug: IV Bisphosphonate q 4 weeks
180 mg AMG 162 (SC) q 12 weeksExperimentalThis is an open-label randomization to receive 180 mg AMG 162 (SC) every 12 weeks during the treatment phase. If subjects are enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 12 weeks.
Receives: Genetic: AMG 162 180 mg (SC) q 12 weeks
180 mg AMG 162 (SC) q 4 weeksExperimentalThis is an open-label randomization to receive 180 mg AMG 162 (SC) every 4 weeks during the treatment phase. If subject is enrolled into the extension phase, they will continue to receive 180 mg AMG 162 (SC) every 4 weeks.
Receives: Genetic: AMG 162- 180 mg q 4 weeks

What is being measured

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

  1. uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13

    Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.

    Measured: 13 weeks

Secondary outcomes (8)

  1. uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25

    Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.

    Measured: 25 weeks

  2. Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25

    Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.

    Measured: Baseline, week 25

  3. Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol

    Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.

    Measured: Day 1, week 25

  4. Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol

    Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.

    Measured: Day 1, week 25

  5. Percent Change of Serum CTX From Baseline to Week 25

    Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.

    Measured: Baseline, week 25

  6. Time to First Skeletal Related Event

    Time from study day 1 to first Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

    Measured: Day 1, week 25

  7. Skeletal Related Events

    Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).

    Measured: Day 1, week 25

  8. Hypercalcemia

    Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria

    Measured: Day 1, week 25

Timeline

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

  1. First posted4 Mar 2005 (estimated)
  2. Study startJan 2005
  3. Primary completionJan 2008
  4. Study completionMar 2010

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104650
Sponsor's protocol ID
20040114
Status last verified
Jan 2011
First submitted
3 Mar 2005
Last updated
24 Jan 2011

Publications

  • Fizazi K, Lipton A, Mariette X, Body JJ, Rahim Y, Gralow JR, Gao G, Wu L, Sohn W, Jun S. Randomized phase II trial of denosumab in patients with bone metastases from prostate cancer, breast cancer, or other neoplasms after intravenous bisphosphonates. J Clin Oncol. 2009 Apr 1;27(10):1564-71. doi: 10.1200/JCO.2008.19.2146. Epub 2009 Feb 23.

    PubMed 19237632

  • Fizazi K, Bosserman L, Gao G, Skacel T, Markus R. Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial. J Urol. 2009 Aug;182(2):509-15; discussion 515-6. doi: 10.1016/j.juro.2009.04.023. Epub 2009 Jun 13.

    PubMed 19524963

  • Jakob T, Tesfamariam YM, Macherey S, Kuhr K, Adams A, Monsef I, Heidenreich A, Skoetz N. Bisphosphonates or RANK-ligand-inhibitors for men with prostate cancer and bone metastases: a network meta-analysis. Cochrane Database Syst Rev. 2020 Dec 3;12(12):CD013020. doi: 10.1002/14651858.CD013020.pub2.

    PubMed 33270906

  • Fizazi K, Bosserman L, Gao G, Skacel T, Markus R. Denosumab treatment of prostate cancer with bone metastases and increased urine N-telopeptide levels after therapy with intravenous bisphosphonates: results of a randomized phase II trial. J Urol. 2013 Jan;189(1 Suppl):S51-7; discussion S57-8. doi: 10.1016/j.juro.2012.11.022.

    PubMed 23234632

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AMG 162 180 mg (SC) q 12 weeks, IV Bisphosphonate q 4 weeks and AMG 162- 180 mg q 4 weeks in people with Bone Metastases in Men With Hormone-Refractory Prostate Cancer and Bone Metastases in Subjects With Advanced Breast Cancer, 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 5 inclusion and 8 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 24 Jan 2011. 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?

Yes. Results are posted in the registry (first posted 7 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13 (time frame: 13 weeks). 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 NCT00104650, which also lists 4 linked publications.

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 24 Jan 2011.

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