Back to resultsStudy of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
Primary Purpose
Advanced Solid Tumors, Multiple Myeloma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ACE-041
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumors
Eligibility Criteria
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.
Sites / Locations
- Acceleron Investigative Site
- Acceleron Investigative Site
- Acceleron Investigative Site
- Acceleron Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ACE-041
Arm Description
Patients assigned to 1 of 9 possible dosing groups
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00996957
First Posted
October 9, 2009
Last Updated
March 14, 2013
Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
1. Study Identification
Unique Protocol Identification Number
NCT00996957
Brief Title
Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
Official Title
A Phase 1 Open-Label, Multiple Dose, Dose Escalation Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACE-041
Arm Type
Experimental
Arm Description
Patients assigned to 1 of 9 possible dosing groups
Intervention Type
Biological
Intervention Name(s)
ACE-041
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Acceleron Investigative Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Acceleron Investigative Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Acceleron Investigative Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Acceleron Investigative Site
City
Salt Lake City
State/Province
Utah
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
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