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: 13.1Level: LLTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-05
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 213

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) = 1.3 x upper limit of normal (ULN) and
international normalized ratio (INR) = 1.3
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)
- Total 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)
Fasting blood glucose = 160 mg/dL (Fasting will require subjects to refrain
from all food and beverage [except water] for at least 8 hours)
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53

Exclusion Criteria

Disease Related
Symptomatic or untreated CNS metastasis - Subjects with CNS metastases that are both treated and stably controlled are
eligible if all of the following apply:
1. 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)
Currently being treated with full dose anti-coagulation therapy (ie coumadin
with a goal INR between 2 to 3, or full dose low molecular weight heparin)
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 = 1 day prior to first
administration of study treatment, and fine needle aspiration, thoracocentesis
or paracentesis = 3 days prior to first administration of study treatment is
acceptable
Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction.
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

Study & Design

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