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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00996957
First received: October 9, 2009
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Multiple Myeloma
Biological: ACE-041
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Acceleron Pharma, Inc.:

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. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: October 2009
Study Completion Date: October 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACE-041
Patients assigned to 1 of 9 possible dosing groups
Biological: ACE-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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996957

Locations
United States, Arizona
Acceleron Investigative Site
Scottsdale, Arizona, United States
United States, North Carolina
Acceleron Investigative Site
Durham, North Carolina, United States
United States, Tennessee
Acceleron Investigative Site
Nashville, Tennessee, United States
United States, Utah
Acceleron Investigative Site
Salt Lake City, Utah, United States
Sponsors and Collaborators
Acceleron Pharma, Inc.
  More Information

No publications provided

Responsible Party: Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00996957     History of Changes
Other Study ID Numbers: A041-01, dalantercept
Study First Received: October 9, 2009
Last Updated: March 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014