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CancerPhase 1/2NCT00770848

AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

A Phase 1/2 study testing AMG 102, Mitoxantrone and Prednisone in people with Cancer and Castrate-Resistant Prostate 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 primary objectives of this study are the following: Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the… Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
AMG 102, Mitoxantrone and Prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
162 participants
Where
No sites listed yet
Study dates
Nov 2008to Apr 2012
Phase
Phase 1/2
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed adenocarcinoma of the prostate
  • Radiographic evidence of metastatic disease
  • Progressive disease meeting at least one of the following criteria:
  • a sequence of at least 2 rising PSA values measured at a minimum of 1 week apart with a 2 ng/mL minimum starting value, or
  • progression according to RECIST criteria for measurable lesions, or
  • appearance of 2 or more new lesions on bone scan.
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  • History of prior taxane-based chemotherapy for metastatic prostate cancer
  • For patients without a history of surgical castration, continued GnRH analog administration is required
  • ECOG Performance status of 0 or 1
  • Life expectancy ≥ 3 months

Who cannot join

  • Treatment with external beam radiotherapy ≤ 14 days before enrollment or radiopharmaceutical ≤8 weeks
  • ≤ 4 weeks since receipt of most recent prior chemotherapy, non-GnRH analog hormonal therapy (except for continuing corticosteroids) or other systemic therapy to treat prostate cancer and <6 weeks since receipt of prior bevacizumab.
  • Known CNS metastases (epidural disease is allowed if it has been treated and there is no progression in the treated area).
  • Significant cardiovascular disease
  • LVEF < 50% by MUGA or ECHO
  • Treatment of infection with systemic anti-infectives within 7 days before enrollment (with the exception of uncomplicated urinary tract infection)
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  • Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except that use of low dose coumarin-type anticoagulants or heparins for prophylaxis against central venous catheter thrombosis is allowed
  • Major surgical procedure ≤30 days before enrollment or not yet recovered from prior major surgery
  • Presence of peripheral edema > Grade 2
  • Known positive test for HIV, hepatitis C, chronic or active hepatitis B
  • Serious or non-healing wound
  • Unable to begin protocol specified treatment within 7 days after enrollment
  • Other investigational procedures are excluded.

About this study

Official title: A Phase 1b/2 Study to Assess the Safety and Efficacy of AMG 102 in Combination With Mitoxantrone and Prednisone in Subjects With Previously Treated Castrate Resistant Prostate Cancer

The primary objectives of this study are the following:

Phase 1b: To identify a safe dose level of AMG 102, up to 15 mg/kg Q3W, to combine with mitoxantrone and prednisone (MP) Phase 2: To estimate with adequate precision the effect of the addition of AMG 102 to MP, compared with placebo plus MP, as assessed by the hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)

Being tested
AMG 102, Mitoxantrone, Placebo, Prednisone
Keywords
CRPC
Medical subject headings
Neoplasms, Prostatic Neoplasms

What participants receive

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

  • AMG 102Drug

    Also called Rilotumumab

    Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.

  • AMG 102Drug

    Also called Rilotumumab

    Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.

  • MitoxantroneDrug

    Administered Q3W for a maximum of 12 cyles

  • PlaceboDrug

    Placebo

  • PrednisoneDrug

    5 mg orally BID

Study groups in NCT00770848
Study groupRoleWhat they receive
Phase 1b - AMG 102OtherPhase 1b is an open-label study with AMG 102 at 15mg/kg de-escalating to 7.5mg/kg and 5mg/kg if needed, will be administered by IV Q3W in combination with MP.
Receives: Drug: AMG 102; Drug: Mitoxantrone; Drug: Prednisone
Phase 2 Arm A - AMG 102 + MPExperimentalAMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.
Receives: Drug: AMG 102; Drug: Mitoxantrone; Drug: Prednisone
Phase 2 Arm C- PLACEBOPlacebo comparatorPlacebo in combination with MP, will be administered by IV Q3W.
Receives: Drug: Mitoxantrone; Drug: Placebo; Drug: Prednisone
Phase 2 Arm B - AMG 102 + MPExperimentalSafe dose level in phase 1b of AMG 102 + MP will be administered by Q3W
Receives: Drug: AMG 102; Drug: Mitoxantrone; Drug: Prednisone

What is being measured

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

  1. Phase 1b - Incidence of adverse events defined by dose-limiting toxicities

    Measured: 21 days after the 6th subjects has recieved 1st cycle of AMG 102 in combination with MP

  2. Phase 2 - Overall survival

    Measured: Entire Study

Secondary outcomes (12)

  1. Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities

    Measured: Treatment Period

  2. Phase 1b - Incidence of anti-AMG 102 antibody formation

    Measured: Entire Study

  3. Phase 1b - Cmax and Cmin of AMG 102 concentration

    Measured: Treatment Period

  4. Phase 2 - Progression-free survival

    Measured: Entire Study

  5. Phase 2 - Maximum percentage reduction in PSA level

    Measured: Entire Study

  6. Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline)

    Measured: Entire Study

  7. Phase 2 - Objective response rate (CR and PR per RECIST with modifications)

    Measured: Entire Study

  8. Phase 2 - Patient Report Outcome including pain-specific measures

    Measured: Treatment Period

  9. Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline

    Measured: Treatment Period

  10. Phase 2 - Incidence of anti-AMG 102 antibody formation

    Measured: Entire Study

  11. Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone

    Measured: Treatment Period

  12. Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy)

    Measured: Treatment Period

Timeline

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

  1. First posted10 Oct 2008 (estimated)
  2. Study startNov 2008
  3. Primary completionJan 2011
  4. Study completionApr 2012

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00770848
Sponsor's protocol ID
20070611
Status last verified
Feb 2014
First submitted
9 Oct 2008
Last updated
10 Mar 2014
Results posted
No

Publications

  • Oliner K.BM Ph2 CRPC.Journal-004521;

  • Ryan CJ, Rosenthal M, Ng S, Alumkal J, Picus J, Gravis G, Fizazi K, Forget F, Machiels JP, Srinivas S, Zhu M, Tang R, Oliner KS, Jiang Y, Loh E, Dubey S, Gerritsen WR. Targeted MET inhibition in castration-resistant prostate cancer: a randomized phase II study and biomarker analysis with rilotumumab plus mitoxantrone and prednisone. Clin Cancer Res. 2013 Jan 1;19(1):215-24. doi: 10.1158/1078-0432.CCR-12-2605. Epub 2012 Nov 7.

    PubMed 23136195

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AMG 102, Mitoxantrone and Prednisone in people with Cancer and Castrate-Resistant Prostate 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 10 inclusion and 13 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 Mar 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Phase 1b - Incidence of adverse events defined by dose-limiting toxicities (time frame: 21 days after the 6th subjects has recieved 1st cycle of AMG 102 in combination with MP). The study lists 2 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 NCT00770848, which also lists 2 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 10 Mar 2014.

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