Resumen

This is a study in patients with chemotherapy induced anemia receiving multi-cycle chemotherapy for the treatment of stage IV non-small cell lung cancer (NSCLC). The primary objective of the study is to demonstrate that overall survival (OS) is not worse in participants on darbepoetin alfa treated to a hemoglobin ceiling of 12.0 g/dL compared to participants treated with placebo.

Descripción detallada

Oversight Authorities continued: Colombia

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.
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 (computed tomography \[CT\], magnetic resonance imaging \[MRI\], or positron emission tomography-computer tomography \[PET/CT\]) 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.

Criterios de exclusión

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 blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 100 mmHg), or as determined by the investigator during screening.
History of neutralizing antibody activity to recombinant human erythropoietin (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 human immunodeficiency virus (HIV) or diagnosis of acquired immunodeficiency syndrome (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 upper limit of normal \[ULN\]) as assessed by the central laboratory during screening.
Abnormal liver function (total bilirubin \> 2X ULN or liver enzymes alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \> 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 red blood cell (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 erythropoiesis stimulating agents (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).

Ubicaciones

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Quilmes, Buenos Aires, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Buenos Aires, Distrito Federal, Argentina

Research Site

Buenos Aires, Distrito Federal, Argentina

Research Site

San Salvador de Jujuy, Jujuy Province, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

San Miguel de Tucumán, Tucumán Province, Argentina

Research Site

Buenos Aires, Argentina

Research Site

La Rioja, Argentina

Research Site

Santa Fe, Argentina

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

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Darbepoetin alfa

Placebo

Ubicaciones

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Patrocinadores