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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2002-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Novel Erythropoiesis Stimulating Protein (NESP; Darbopoetin Alfa) for the Treatment of Anemia in Lung Cancer Patients Receiving Multi-cycle Platinum-Containing Chemotherapy

NCT03776032

Anemia

COMPLETED PHASE3

Evaluating Treatment of Anemia in Subjects With Non-Myeloid MalignanciesReceiving Multicycle Chemotherapy

NCT00111462

Anemia Non-Myeloid Malignancies Cancer

COMPLETED PHASE2

Chemotherapy Related Anemia

NCT00035607

Anemia Non-Myeloid Malignancies

COMPLETED PHASE2

Anemia in Patients With a Non-Myeloid Malignancy

NCT00038064

Neoplasms Anemia

COMPLETED PHASE3

Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy

NCT00858364

Non-Small Cell Lung Cancer Anemia Cancer +1 more

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NESP - Schedule 1 Part A

Part A - 4.5, 6.75, 9.0 or 13.5 mcg/kg Q3W for 12 weeks

Group Type EXPERIMENTAL

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Intervention Type DRUG

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

NESP - Schedule 2 Part A

NESP 9.0, 12.0, 15.0 or 18.0 mcg/kg Q4W for 12 weeks

Group Type EXPERIMENTAL

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Intervention Type DRUG

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Placebo - Schedule 1 Part A

Placebo Q3W for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

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.

Group Type EXPERIMENTAL

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Intervention Type DRUG

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Placebo - Schedule 2 Part A

Placebo Q4W for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

NESP - Schedule 2 Part B

Open-label NESP at the dose of study drug administered at the end of Part A

Group Type EXPERIMENTAL

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Intervention Type DRUG

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Intervention Type DRUG

Novel Erythropoiesis Stimulating Protein (NESP) (darbepoetin alfa)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

Accepts Healthy Volunteers

No