Amgen Protocol 20070782

Study #20070782

Condition / Intervention

Lung Cancer

Purpose

A randomized, double-blind, placebo-controlled study to evaluate the long-term safety and efficacy of darbepoetin alfa administered at 500ug once-every-3-weeks in anemic subjects with advanced stage non-small cell lung cancer receiving multi cycle chemotherapy.

Investigator

Neal A Fischbach, MD

Contact Information

For more information about this study and to inquire about eligibility, (203) 384-3611.

More Information

View this trial on ClinicalTrials.gov

Eligibility

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).