Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma

Phase 1

Completed

• Conditions: Advanced Solid Tumors; Multiple Myeloma
• Interventions: Biological: ACE-041

• Registration Number: NCT00996957
• Lead Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-16
• Primary Completion: 2012-06
• Study Completion: 2012-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-14
• Last Update Posted: 2013-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACE-041	ACE-041	Patients assigned to 1 of 9 possible dosing groups

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Acceleron Investigative Site; 🇺🇸 Salt Lake City, Utah, United States