Advanced Solid Tumors, Multiple Myeloma
Conditions
Brief summary
For cancer cells to grow, they need to have nutrients supplied to them through blood vessels. The study drug, ACE-041, is designed to work by blocking the growth of those blood vessels and preventing cancer cells from growing. The purpose of this study is to establish safe dose levels of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma following multiple dose administration. This study will also evaluate if ACE-041 has an effect on tumors.
Interventions
BIOLOGICALACE-041
Subcutaneous dose of ACE-041 approximately once every 3 weeks for a total of 4 doses. If disease stays the same or gets better, additional study drug may be offered.
Sponsors
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of metastatic or unresectable advanced solid tumors (solid tumors must be measurable) or relapsed/refractory multiple myeloma for which the disease has progressed despite available standard therapies or for which no standard therapy exists. * Life expectancy of at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG) Performance status of 0, 1, or 2 (not declining within 2 weeks prior to study day 1).
Exclusion criteria
* Central nervous system (CNS) metastases. * Chemotherapy or other anti-cancer therapy within 4 weeks prior to study day 1, and/or nitrosoureas within the 6 weeks prior to study day 1. * Lack of recovery from all toxic effects of previous chemotherapy, radiation therapy, biologic therapy, and/or experimental therapy with the exception of alopecia. * Radiation therapy within 4 weeks prior to study day 1. * Clinically significant pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal or genitourinary disease unrelated to underlying solid tumor or multiple myeloma * Significant cardiac risk (e.g. history of myocardial infarction, unstable angina, pulmonary hypertension, clinically significant arrhythmia, congestive heart failure within 1 year prior to study day 1). * Diagnosis or family history of hereditary hemorrhagic telangiectasia. * Major surgery within 6 weeks prior to study day 1. * Parenteral antibiotics, or any life-threatening or active infection requiring parenteral antibiotic therapy within 1 month prior to study day 1. * Therapeutic anti-coagulation. * Uncontrolled hypertension. * Autoimmune or hereditary hemolysis. * Clinically significant gastrointestinal bleeding or any other clinically significant active bleeding within 3 months prior to study day 1. * Treatment with another investigational drug or device, or approved therapy for investigational use within 28 days prior to study day 1. * Pregnancy or lactation for female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of ACE-041 in patients with advanced solid tumors or relapsed/refractory multiple myeloma by monitoring adverse events, clinical laboratory tests, vital signs, physical examinations, and anti-drug antibody tests. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetic effect of ACE-041 through the collection of blood samples and to evaluate the preliminary anti-tumor activity of ACE-041 through tumor response evaluation, collection of blood biomarkers, and imaging techniques. | 4 months |
Countries
United States
Outcome results
None listed