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

Sponsor

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)

Overall Status

Completed

CT.gov ID

NCT00996957

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors Multiple Myeloma	Biological: ACE-041	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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. [4 months]

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. [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Acceleron Investigative Site	Scottsdale	Arizona	United States
2	Acceleron Investigative Site	Durham	North Carolina	United States
3	Acceleron Investigative Site	Nashville	Tennessee	United States
4	Acceleron Investigative Site	Salt Lake City	Utah	United States

Sponsors and Collaborators

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

ClinicalTrials.gov Identifier:

NCT00996957

Other Study ID Numbers:

A041-01
dalantercept

First Posted:

Oct 16, 2009

Last Update Posted:

Mar 18, 2013

Last Verified:

Mar 1, 2013

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Mar 18, 2013