Clinical trial NCT00996957: Study of ACE-041 in Patients With Advanced Solid Tumors or Relapsed/Refractory Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Multiple Myeloma
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2009-10-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 4 months
Secondary outcomes:
measure: 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.
timeFrame: 4 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Acceleron Investigative Site
state: Arizona
city: Durham
country: United States
facility: Acceleron Investigative Site
state: North Carolina
city: Nashville
country: United States
facility: Acceleron Investigative Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Acceleron Investigative Site
state: Utah
Study officials:
References: