NCT00770848

Brief 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 hazard ratio (HR) for overall survival (OS) of previously treated subjects with castrate-resistant prostate cancer (CRPC)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_1 cancer

Timeline
Completed

Started Nov 2008

Typical duration for phase_1 cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 10, 2014

Status Verified

February 1, 2014

Enrollment Period

2.2 years

First QC Date

October 9, 2008

Last Update Submit

February 6, 2014

Conditions

CancerCastrate-Resistant Prostate CancerMestastatic Prostate CancerProstate Cancer

Keywords

CRPC

Outcome Measures

Primary Outcomes (2)

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

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

  • Phase 2 - Overall survival

    Entire Study

Secondary Outcomes (12)

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

    Treatment Period

  • Phase 1b - Incidence of anti-AMG 102 antibody formation

    Entire Study

  • Phase 1b - Cmax and Cmin of AMG 102 concentration

    Treatment Period

  • Phase 2 - Progression-free survival

    Entire Study

  • Phase 2 - Maximum percentage reduction in PSA level

    Entire Study

  • +7 more secondary outcomes

Study Arms (4)

Phase 1b - AMG 102

OTHER

Phase 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.

Drug: AMG 102Drug: MitoxantroneDrug: Prednisone

Phase 2 Arm A - AMG 102 + MP

EXPERIMENTAL

AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.

Drug: AMG 102Drug: MitoxantroneDrug: Prednisone

Phase 2 Arm C- PLACEBO

PLACEBO COMPARATOR

Placebo in combination with MP, will be administered by IV Q3W.

Drug: MitoxantroneDrug: PlaceboDrug: Prednisone

Phase 2 Arm B - AMG 102 + MP

EXPERIMENTAL

Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W

Drug: AMG 102Drug: MitoxantroneDrug: Prednisone

Interventions

AMG 102DRUG

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

Also known as: Rilotumumab
Phase 2 Arm A - AMG 102 + MPPhase 2 Arm B - AMG 102 + MP
MitoxantroneDRUG

Administered Q3W for a maximum of 12 cyles

Phase 1b - AMG 102Phase 2 Arm A - AMG 102 + MPPhase 2 Arm B - AMG 102 + MPPhase 2 Arm C- PLACEBO
PlaceboDRUG

Placebo

Phase 2 Arm C- PLACEBO
PrednisoneDRUG

5 mg orally BID

Phase 1b - AMG 102Phase 2 Arm A - AMG 102 + MPPhase 2 Arm B - AMG 102 + MPPhase 2 Arm C- PLACEBO

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

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

    BACKGROUND

  • 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.

    PMID: 23136195BACKGROUND

Related Links

MeSH Terms

Conditions

NeoplasmsProstatic Neoplasms

Interventions

rilotumumabMitoxantronePrednisone

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring Compounds

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

November 1, 2008

Primary Completion

January 1, 2011

Study Completion

April 1, 2012

Last Updated

March 10, 2014

Record last verified: 2014-02