A Phase 1 Open-Label, Multiple Dose, Dose Escalation Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
- 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
- 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).
- 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
- 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.