Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy

May 6, 2013 updated by: Amgen

A Randomised, Double-blind, Placebo-controlled, Dose-finding Study of Novel Erythropoiesis Stimulating Protein (NESP) Administered by Subcutaneous (SC) Injection for the Treatment of Anaemia in Subjects With Solid Tumours Receiving Multicycle Chemotherapy

The purpose of this study is to assess the safety of NESP administered by SC injection in subjects with solid tumours and anaemia receiving multicycle chemotherapy.

Subjects in this study enter one of two schedules: Schedule 1 or Schedule 2. Schedule 1 is a sequential dose escalation study which consists of Parts A and B. Part A is the initial treatment phase, where the clinically effective dose (CED) of NESP administered every 3 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.

Schedule 2 is a parallel dose-finding study and also consists of Parts A and B. Part A is the initial treatment phase, where the CED of NESP administered every 4 weeks will be determined after 12 weeks of treatment. Part B is an optional 12-week, open-label, dose-maintenance phase that follows Part A.

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 (Anticipated)

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.
405

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject with solid tumour(s)
  • Anaemia (hgb less than or equal to 11.0 g/dL
  • Planned to receive cyclic chemotherapy
  • At least 6-month life expectancy
  • Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
  • Adequate renal and liver function
  • At least 18 years of age

Exclusion Criteria:

  • Central nervous system disease
  • Iron deficiency
  • Received more than 2 RBC transfusions within 4 weeks before randomisation or any RBC transfusion within 2 weeks before randomisation
  • Received recombinant human erythropoietin (rHuEPO) therapy within 8 weeks before randomisation
  • History of any seizure disorder
  • Cardiac disease
  • Active infection or inflammatory disease
  • Known positive test for HIV infection
  • Known primary haematologic disorder which could cause anaemia
  • Use of other investigational agent(s)/device(s)
  • Pregnant or breast feeding
  • Known hypersensitivity to any recombinant mammalian derived product

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: Quadruple

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.
Experimental: NESP - Schedule 1 Part A
Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Experimental: NESP - Schedule 2 Part A
NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Placebo Comparator: Placebo - Schedule 1 Part A
Placebo Q3W for 12 weeks
Drug: Placebo
Placebo
Experimental: NESP - Schedule 1 Part B
Open-label NESP at the dose of study drug administered at the end of Part A. Increase dose at week 19 if hgb < 13.0g/dL and/or RBC transfusion in previous 2 weeks.
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Placebo Comparator: Placebo - Schedule 2 Part A
Placebo Q4W for 12 weeks
Drug: Placebo
Placebo
Experimental: NESP - Schedule 2 Part B
Open-label NESP at the dose of study drug administered at the end of Part A
Drug: Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)
Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

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
Occurence of adverse events and antibody formation to NESP
Time Frame: throughout the study
throughout the 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
Number and proportion of subjects who receive any RBC transfusion, number of units of RBC transfused, and number of days with at least one RBC transfusion during weeks 1-12, 1-4, 5-8, 9-12, and 5-12, with emphasis on the 5-12 week window
Time Frame: during weeks 1-12, 1-4, 5-8, 9-12, and 5-12
during weeks 1-12, 1-4, 5-8, 9-12, and 5-12
Selected domains of quality of life (QOL) measured by FACT-G and FACT-anaemia scales, BSI depression and BSI anxiety scales, and de novo questions
Time Frame: throughout the study
throughout the study
Relationship between these QOL measurements and hgb
Hgb correction to greater than or equal to 12.0 g/dL in the absence of a red blood cell (RBC) transfusion during the preceding 4 weeks during treatment phase
Time Frame: during treatment phase
during treatment phase
Number and proportion of subjects, during the treatment phase, who achieve a hemoglobin (hgb) response
Time Frame: during the treatment phase
during the treatment phase
Time to hgb response and hgb correction after the initiation of treatment
Time Frame: after the initiation of treatment
after the initiation of treatment
Change in hgb measured at the end of the treatment phase compared to baseline
Time Frame: baseline to end of the treatment phase
baseline to end of the treatment phase

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.
July 1, 1999

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.
March 1, 2002

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.
June 1, 2002

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 4, 2007

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 4, 2007

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 8, 2007

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.
May 8, 2013

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.
May 6, 2013

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.
May 1, 2013

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.
  • 980291

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.

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