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

Acceleron Pharma

Status and phase

Completed

Phase 1

Conditions

Multiple Myeloma

Advanced Solid Tumors

Treatments

Biological: ACE-041

Study type

Interventional

Funder types

Industry

Identifiers

NCT00996957

A041-01

dalantercept (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.