A Phase 1b/ 2 Trial of AMG 479 or AMG 102 in Combination with Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer

• Conditions: Previously Untreated Extensive Stage Small Cell Lung Cancer (SCLC); MedDRA version: 9.1Level: LLTClassification code 10041067Term: Small cell lung cancer

• Registration Number: EUCTR2008-003292-42-NL
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-20
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Disease related
• Histologically or cytologically confirmed SCLC
• Extensive disease, defined by at least one of the following criteria:
- No limited disease (ie, no disease confined to the ipsilateral hemithorax, which can be safely encompassed within a tolerable radiation field)
- Extrathoracic metastases
- Malignant pericardial or pleural effusion
- Contralateral hilar adenopathy
• Measurable or non-measurable disease, as defined by modified RECIST (see Appendix E)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (see Appendix I)
• Life expectancy (with therapy) = 3 months
Demographic
• Woman or man = 18 years old
Ethical
• Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1)
Laboratory
• Hematological function (within 3 days prior to enrollment), as follows:
- Absolute neutrophil count (ANC) = 1.5 x 109/L
- Platelet count = 100 x 109/L
- Hemoglobin = 9 g/dL
• Partial thromboplastin time (PTT) = 1.2 x upper limit of normal (ULN) and international normalized ratio (INR) = 1.5
• Renal function, as follows:
- Creatinine (Cr) clearance (CrCl) = 60 mL/minute (min); calculated by Cockcroft-Gault formula (see Appendix D) as follows:
?? Male CrCl = (140 - age) x (weight in Kg) / (serum Cr x 72)
?? Female CrCl = (140 - age) x (weight in Kg) x 0.85 / (serum Cr x 72)
• Hepatic function, as follows:
- Aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN if attributable to liver metastases)
- Alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN if attributable to liver metastases)
- Alkaline phosphatase = 2.5 x ULN (= 5 x ULN if attributable to bone and/or liver metastases)
- Bilirubin = 1.5 x ULN (= 3 x ULN for subjects with UGT1A1 promoter polymorphism ie, Gilbert syndrome, confirmed by genotyping or Invader UGT1A1 molecular assay prior to enrollment)
• Adequate glycemic function, for subjects with known diabetes (Type 1 or 2), as follows:
- Must be controlled with a glycosylated hemoglobin (HgbA1c) of = 8.0%
- Documented fasting blood sugars = 160 mg/dL. Diabetic subjects who have recently had their glycemic control regimens adjusted and have documented fasting blood glucose concentrations = 160 mg/dL may be considered, regardless of HgbA1c value, if per investigator discretion are considered to have adequate glycemic function
• Negative pregnancy test (urine or serum) within 7 days prior to enrollment (women of child-bearing potential only)
General
• Plan to begin protocol specific therapy = 7 days after enrollment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Disease Related
• Symptomatic or untreated CNS metastasis
- Subjects with CNS metastases that are both definitively treated and stably controlled are eligible if all of the following apply: 1) definitive therapy has been administered (surgery and/or radiation therapy); 2) there is no additional treatment planned for brain metastases; 3) the subject is clinically stable; and 4) the subject is off corticosteroids or on a stable dose of corticosteroids for at least 2 weeks prior to enrollment
• Any prior or synchronous malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for = 3 years prior to enrollment and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
Cancer Therapy
• Prior chemotherapy, chemo-radiation or investigational agent for the treatment of SCLC
- Prior palliative radiotherapy to sites of distant metastasis is allowed (if completed = 7 days prior to enrollment)
- Prior treatment of CNS metastasis is allowed (as defined in Section 4.2.1)
• Currently or previously treated with biological, immunological or other anti-tumor therapies for SCLC
• Prior radiotherapy to > 25% of the bone marrow
Medications/ Treatments
• Recent infection requiring systemic anti-infective treatment that was completed = 14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection)
Medical Conditions
• History of bleeding diathesis
• Current serious or non-healing wound or ulcer
• Known positive test for human immunodeficiency virus, hepatitis C, chronic or active hepatitis B
• Any clinically significant medical or psychiatric condition, co-morbid disease, addictive disorder, or laboratory abnormality (eg, cardiovascular disease or chronic obstructive pulmonary disease), which may increase the risks associated with study participation or study treatments or could interfere with the safe delivery of study treatment or increase risk of toxicity
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
• Major surgical procedure within 28 days prior to enrollment, or not yet recovered from major surgery
• Minor surgical procedures within 7 days prior to enrollment, or not yet recovered from minor surgery
Note: uncomplicated placement of vascular access device, fine needle aspiration, thoracocentesis or paracentesis = 3 days prior to enrollment is acceptable
General
• Inability to tolerate IV drug administration
• Subject is currently enrolled in or has not yet completed at least 30 days prior to enrollment since ending other investigational device or clinical study(s)
• Subject of child-bearing potential is evidently pregnant (eg, positive human chorionic gonadotropin test) or is breast feeding
• Woman or man with partner of childbearing potential not consenting to use adequate contraceptive precautions ie, double barrier contraceptive methods (eg, diaphragm plus condom), or abstinence during the course of the study and for 3 months after the last study drug administration for women, and 6 months for men
• Subject has known sensitivity to any of the products to be administered during the study
• Subj

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified