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Anemia Treatment for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy
This study is currently recruiting participants.
Verified January 2012 by Amgen

First Received on March 5, 2009.   Last Updated on January 18, 2012   History of Changes
Sponsor: Amgen
Information provided by: Amgen
ClinicalTrials.gov Identifier: NCT00858364
  Purpose

This is a double-blind, randomized, placebo-controlled phase 3 non-inferiority study in subjects with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of metastatic (stage IV) Non-Small Cell Lung Cancer (NSCLC). Approximately 3000 subjects with metastatic (stage IV) NSCLC expecting to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy will be enrolled into the study. Subjects will be randomized in a 2:1 allocation (Group A: darbepoetin alfa 500 µg every 3 weeks <Q3W>, Group B: placebo Q3W)


Condition Intervention Phase
Non-Small Cell Lung Cancer
Anemia
Cancer
Lung Cancer
Drug: darbepoetin alfa 500 mcg Q3W
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Long-term Safety and Efficacy of Darbepoetin Alfa Administered at 500 µg Once-Every-3-Weeks in Anemic Subjects With Advanced Stage Non-small Cell Lung Cancer Receiving Multi-cycle Chemotherapy

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: from randomization until death or end of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of neutralizing antibody formation to darbepoetin alfa [ Time Frame: first dose of investigative product to the end of treatment period ] [ Designated as safety issue: Yes ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from study day 1 to end of treatment period [ Time Frame: study day 1 until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of at least 1 Red Blood Cell (RBC) transfusion or hemoglobin less than or equal to 8.0 g/dL from week 5 (day 29) to end of efficacy treatment period [ Time Frame: Study day 29 to end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) such as thrombovascular events (TVE), venous thromboembolic events (VTE), and AEs associated with Red Blood Cell (RBC) transfusions [ Time Frame: Randomization to 30 days after last dose of darbepoetin alfa ] [ Designated as safety issue: Yes ]
  • Change in hemoglobin from baseline to end of efficacy treatment period [ Time Frame: screening until end of efficacy treatment period ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: randomization to subjects developing tumor progression ] [ Designated as safety issue: Yes ]
  • Progression-free survival (PFS) [ Time Frame: from randomization until disease progression ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: June 2009
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
darbepoetin alfa 500 µg (Q3W)
Drug: darbepoetin alfa 500 mcg Q3W
darbepoetin alfa 500 mcg (Q3W)
Placebo Comparator: B
Placebo Q3W
Drug: placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with stage IV NSCLC (not recurrent or re-staged).
  • Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
  • Eastern Cooperative Oncology Group performance status of 0 or 1 as assessed within 21 days prior to randomization.
  • 18 years of age or older at screening.
  • Life expectancy greater than 6 months based on the judgment of the investigator and documented during screening.
  • Hemoglobin level less than or equal to 11.0 g/dL as assessed by the local laboratory; sample obtained within 7 days prior to randomization (retest in screening is acceptable).
  • Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
  • Subjects must have had a baseline scan (CT, MRI, or PET/CT) of the chest to assess disease burden before starting on first line chemotherapy for NSCLC and those images must have been reviewed by the investigator prior to randomization. If the scan was performed more than 28 days prior to randomization, an additional scan must be performed and reviewed by the investigator to confirm that the patient has not progressed before randomization.
  • Before any study-specific procedure, the appropriate written informed consent must be obtained from the subject or a legally accepted representative .

Exclusion Criteria:

  • Known primary benign or malignant hematologic disorder which can cause anemia.
  • History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years.
  • Received any prior adjuvant or neoadjuvant therapy for NSCLC.
  • Subjects with a history of brain metastasis .
  • Uncontrolled hypertension (systolic BP > 160 mmHg or diastolic BP > 100 mmHg), or as determined by the investigator during screening.
  • History of neutralizing antibody activity to rHuEPO or darbepoetin alfa.
  • Uncontrolled angina, uncontrolled heart failure, or uncontrolled cardiac arrhythmia as determined by the investigator at screening. Subjects with known myocardial infarction within 6 months prior to randomization.
  • Subjects with a history of seizure disorder taking anti-seizure medication within 30 days prior to randomization.
  • Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
  • Known seropositivity for HIV or diagnosis of AIDS, positive for hepatitis B surface antigen, or seropositive for hepatitis C virus
  • History of pure red cell aplasia
  • History of deep venous thrombosis or embolic event (eg, pulmonary embolism) within 6 months prior to randomization.
  • Transferrin saturation < 20% and ferritin < 50 ng/mL as assessed by the central laboratory during screening. Subjects must have both to be excluded (supplementation and retest acceptable).
  • Abnormal renal function (serum creatinine level > 2X ULN) as assessed by the central laboratory during screening.
  • Abnormal liver function (total bilirubin > 2X ULN or liver enzymes ALT or AST > 2.5X ULN for subjects without liver metastasis or ≥ 5X ULN for subjects with liver metastasis) as assessed by the central laboratory during screening. Subjects with documented Gilbert's Disease may be eligible.
  • Received any RBC transfusion within 28 days prior to randomization.
  • Plan to receive any RBC transfusion between randomization and study day 1.
  • Known previous treatment failure to ESAs (eg, rHuEPO, darbepoetin alfa).
  • ESA therapy within the 28 days prior to randomization.
  • Known hypersensitivity to recombinant ESAs or the excipients contained within the investigational product.
  • Less than 30 days since receipt of any investigational product or device. Investigational use/receipt of a medicinal product or device that has been approved by the country's local regulatory authority for any indication is permitted.
  • Subjects of reproductive potential who are pregnant, breast feeding or not willing to use effective contraceptive precautions during the study and for at least one month after the last dose of investigational product in the judgment of the investigator (including females of childbearing potential who are partners of male subjects).
  • Previously randomized to this study.
  • Investigator has concerns regarding the ability of the subject to give written informed consent and/or to comply with study procedures (including availability for follow up visits.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00858364

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 449 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00858364     History of Changes
Other Study ID Numbers: 20070782
Study First Received: March 5, 2009
Last Updated: January 18, 2012
Health Authority: Greece: Ministry of Health & Social Solidarity, National Organization for Medicines;   Greece: National Ethics Committee;   Argentina: Ministry of Health;   Austria: Central Ethics Committee;   Greece: National Organization for Medicines;   Hong Kong: Department of Health;   India: Central Drugs Standard Control Organization;   Ireland: Irish Medicines Board;   Israel: Ministry of Health;   Italy: Local Ethics Committees;   Italy: Ministry of Health;   Italy: The Istituto Superiore di Sanità (ISS) within the Italian National Health Service. Its activities include research, control, training and consultation in the interest of public health protection. Responsible to approved the phase 1 studies.;   Luxembourg: Comité National d'Ethique de Recherche;   Luxembourg: Direction de la Santé, Division de la Pharmacie et des Médicaments;   Mexico: COFEPRIS;   Mexico: Ministry of Health;   Mexico: SSA (Secretaria de Salud Publica);   Netherlands: CCMO (Centrale Commissie Mensgebonden Onderzoek): Central Committee Human Bound Research;   Netherlands: Medicines Evaluation Board;   Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider;   Phillippines: the Bureau of Food and Drugs;   Poland: Drug Institut;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Romaina: National Medicines Agency;   Romania: Ministry of Health and the Family;   Romania: Romanian National Drug Agency;   Russia: Federal Service for Surveillance in the field of Healthcare and Social Development (a body of the Ministry of Health);   Russia: Ministry of Health;   Serbia: Medicine and Medical Devices Agency of Serbia;   Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP);   Slovenia: National Medical Ethics Committee (Komisija Republike Slovenije Za Medicinsko Etiko);   South Africa: Department of Health;   Spain: reference Ethics Committee;   Spain: Spanish Agency of Medicines;   Spain: Spanish Drug Agency;   Switzerland: Agency for Therapeutic Products;   Switzerland: Local Ethics Committee;   Taiwan: Department of Health;   Taiwan: Taiwan Food and Drug Administration;   Taiwan: Taiwan Provincial Department of Health;   Ukraine: Ministry of Health;   Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre);   United Kingdom: Medicines and Healthcare Products Regulatory Agency;   United States: Food and Drug Administration;   United States: Institutional Review Board;   Austria: Federal Ministry for Health and Women;   Austria: Secretariat of Health;   Belgium: Directorate general for the protection of Public health: Medicines;   Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment;   Belgium: Pharmaceutical Inspectorate;   Brazil: Ministry of Health;   Bulgaria: Bulgarian Drug Agency;   Bulgaria: Ministry of Health;   Canada: Health Canada;   Canada: Institutional Review Board;   Chile: Health Ministry;   Croatia: Central Ethics Committee Sredisnje Eticko Povjerenstvo;   Croatia: Ministarstvo zdravstva i socijalne skrbi (Ministry of Health and Social Welfare);   Czech Republic: State Institute for Drug Control;   EU: CHMP;   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Amgen:
darbepoetin alfa
non-small cell lung cancer
Aranesp
chemotherapy
chemotherapy induce anemia
advanced lung cancer
malignant pleural effusion
metastatic lung cancer
NSCLC
anemia
lung cancer
pleural effusion
Stage IIIB lung cancer
Stage IV lung cancer

Additional relevant MeSH terms:
Anemia
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Hematologic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012