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

February 6, 2014 updated by: Amgen

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the prostate
  • Radiographic evidence of metastatic disease

  • Progressive disease meeting at least one of the following criteria:

    1. 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
    2. progression according to RECIST criteria for measurable lesions, or
    3. 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Phase 1b - AMG 102
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 102
Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.
Other Names:
  • Rilotumumab
Drug: AMG 102
Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.
Other Names:
  • Rilotumumab
Drug: Mitoxantrone
Administered Q3W for a maximum of 12 cyles
Drug: Prednisone
5 mg orally BID
Experimental: Phase 2 Arm A - AMG 102 + MP
AMG 102 safe dose level in phase 1b in combination with MP, will be administered by IV Q3W.
Drug: AMG 102
Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.
Other Names:
  • Rilotumumab
Drug: AMG 102
Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.
Other Names:
  • Rilotumumab
Drug: Mitoxantrone
Administered Q3W for a maximum of 12 cyles
Drug: Prednisone
5 mg orally BID
Placebo Comparator: Phase 2 Arm C- PLACEBO
Placebo in combination with MP, will be administered by IV Q3W.
Drug: Placebo
Placebo
Drug: Mitoxantrone
Administered Q3W for a maximum of 12 cyles
Drug: Prednisone
5 mg orally BID
Experimental: Phase 2 Arm B - AMG 102 + MP
Safe dose level in phase 1b of AMG 102 + MP will be administered by Q3W
Drug: AMG 102
Investigational product to be given at safe dose from phase 1b, will be administered by IV Q3W.
Other Names:
  • Rilotumumab
Drug: AMG 102
Investigational product to be given at 15mg/kg, 7.5mg/kg, or 5mg/kg depending on assignment, will be administered by IV Q3W.
Other Names:
  • Rilotumumab
Drug: Mitoxantrone
Administered Q3W for a maximum of 12 cyles
Drug: Prednisone
5 mg orally BID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
21 days after the 6th subjects has recieved 1st cycle of AMG 102 in combination with MP
Phase 2 - Overall survival
Time Frame: Entire Study
Entire Study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Phase 1b - Incidence of adverse events, abnormal laboratory values not defined as dose limiting toxicities
Time Frame: Treatment Period
Treatment Period
Phase 1b - Incidence of anti-AMG 102 antibody formation
Time Frame: Entire Study
Entire Study
Phase 1b - Cmax and Cmin of AMG 102 concentration
Time Frame: Treatment Period
Treatment Period
Phase 2 - Progression-free survival
Time Frame: Entire Study
Entire Study
Phase 2 - Maximum percentage reduction in PSA level
Time Frame: Entire Study
Entire Study
Phase 2 - PSA response rate (≥50% reduction in PSA values from baseline)
Time Frame: Entire Study
Entire Study
Phase 2 - Objective response rate (CR and PR per RECIST with modifications)
Time Frame: Entire Study
Entire Study
Phase 2 - Patient Report Outcome including pain-specific measures
Time Frame: Treatment Period
Treatment Period
Phase 2 - Incidence of adverse events and significant laboratory value changes from baseline
Time Frame: Treatment Period
Treatment Period
Phase 2 - Incidence of anti-AMG 102 antibody formation
Time Frame: Entire Study
Entire Study
Phase 2 - Cmax and Cmin of AMG 102; Cmax and AUC for Mitoxantrone
Time Frame: Treatment Period
Treatment Period
Phase 2 - Percentage change in PSA levels from baseline to 12 weeks (or earlier for those who discontinue therapy)
Time Frame: Treatment Period
Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20070611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings