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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996957
• Other study ID #: A041-01
• Secondary ID: dalantercept
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2009
• Last updated: March 14, 2013
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: March 2013
• Source: Acceleron Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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.

Locations

Country	Name	City	State
United States	Acceleron Investigative Site	Durham	North Carolina
United States	Acceleron Investigative Site	Nashville	Tennessee
United States	Acceleron Investigative Site	Salt Lake City	Utah
United States	Acceleron Investigative Site	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Acceleron Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No