NCT00102830
Completed
Phase 1
A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tumors
- Sponsor
- Amgen
- Primary Endpoint
- Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have evaluable disease - Must be able to undergo MRI evaluation:
- •Must not have cardiac pacemakers or neurostimulators not specifically approved for use in the MRI environment;
- •Must not have metal implants, other than those approved as safe for use in MRI;
- •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
- •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
Outcomes
Primary Outcomes
Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.
Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.
Secondary Outcomes
- Changes in DCE-MRI imaging results measured at baseline, Week 1, and Week 4.
- Changes in blood levels of angiogenic cytokines measured at baseline, Day 3, Weeks 2, 4, 10, and every 8 weeks thereafter.
- Anti-AMG 386 antibody formation measured at baseline, weeks 2, 4, 6, and every 4 weeks thereafter.
- Tumor response measure by CT scan at baseline, Week 4, and every 8 weeks thereafter.
Similar Trials
Recruiting
Phase 1
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.AnemiaNCT05773586Ascentage Pharma Group Inc.105
Active, not recruiting
Phase 1
A Study to Evaluate the Safety,PK and PD of APG-2575 in Patients With Hematologic MalignanciesChronic Lymphocytic LeukemiaNon Hodgkin LymphomaNCT03913949Ascentage Pharma Group Inc.74
Withdrawn
Phase 1
3D011-08 Monotherapy in Subjects With Advanced Solid TumorsSolid Tumor, AdultNCT050995363D Medicines (Beijing) Co., Ltd.
Completed
Phase 1
Study of Danicopan in Participants of Japanese DescentHealthyNCT04451434Alexion Pharmaceuticals, Inc.9
Recruiting
Phase 1
Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children With Rifampicin-Resistant TuberculosisTuberculosisRifampicin Resistant TuberculosisNCT05586230National Institute of Allergy and Infectious Diseases (NIAID)72