Clinical trial NCT00102830: Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors
Official title: A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Solid Tumor
Metastatic Cancer
Advanced Solid Tumors
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-02-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK) profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria: - Have evaluable disease - Must be able to undergo MRI evaluation:

1. Must not have cardiac pacemakers or neurostimulators not specifically approved for use in the MRI environment;
2. Must not have metal implants, other than those approved as safe for use in MRI;
3. Must not be claustrophobic or have physical characteristics that will preclude undergoing MRI; - Subjects enrolling to the Dose Expansion Cohort must have at least one tumor that is amenable to DCE-MRI evaluation (e.g., greater than or equal to 3 cm lesion outside the thoracic cavity) - Have Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Presence of untreated CNS metastasis or symptoms of brain metastases - Presence of leukemia or myelodysplastic syndrome - History of high-dose chemotherapy requiring bone marrow or peripheral stem cell support - Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[NYHA greater than class II\], uncontrolled hypertension \[diastolic greater than 85 mmHg; systolic greater than 145 mmHg\] or cardiac arrhythmia) - History of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) within 6 months of study day 1 - History of bleeding diathesis or hypercoagulopathy within 6 months of study day 1 - Active peptic ulcer disease or gastritis - Unresolved toxicities from prior anti-cancer therapy, excluding alopecia - Anti-tumor treatment within 3 weeks of study day 1. If anti-tumor treatment was an antibody therapy, the interval must be 6 weeks - Anticoagulation therapy, except a low dose of Coumadin™ (less than 2 mg) for prophylaxis against central catheter-related thrombosis - Major surgery within 4 weeks of study day 1 - History of allergic reaction to bacterially produced proteins - Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus or chronic hepatitis B infection - Pregnant or breastfeeding - Not using adequate contraceptive precautions, in the judgment of the investigator

Primary outcomes:
measure: Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.
measure: Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.
Secondary outcomes:
measure: Changes in DCE-MRI imaging results measured at baseline, Week 1, and Week 4.
measure: Changes in blood levels of angiogenic cytokines measured at baseline, Day 3, Weeks 2, 4, 10, and every 8 weeks thereafter.
measure: Anti-AMG 386 antibody formation measured at baseline, weeks 2, 4, 6, and every 4 weeks thereafter.
measure: Tumor response measure by CT scan at baseline, Week 4, and every 8 weeks thereafter.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Lu JF, Rasmussen E, Karlan BY, Vergote IB, Navale L, Kuchimanchi M, Melara R, Stepan DE, Weinreich DM, Sun YN. Exposure-response relationship of AMG 386 in combination with weekly paclitaxel in recurrent ovarian cancer and its implication for dose selection. Cancer Chemother Pharmacol. 2012 May;69(5):1135-44. doi: 10.1007/s00280-011-1787-5. Epub 2012 Jan 1.