Status:
COMPLETED
Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions:
Advanced Solid Tumors
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00996957
Start Date
October 1 2009
End Date
October 1 2012
Last Update
March 18 2013
Active Locations (4)
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1
Acceleron Investigative Site
Scottsdale, Arizona, United States
2
Acceleron Investigative Site
Durham, North Carolina, United States
3
Acceleron Investigative Site
Nashville, Tennessee, United States
4
Acceleron Investigative Site
Salt Lake City, Utah, United States