NCT00996957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 18, 2013

Status Verified

March 1, 2013

Enrollment Period

2.7 years

First QC Date

October 9, 2009

Last Update Submit

March 14, 2013

Conditions

Advanced Solid TumorsMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

ACE-041

EXPERIMENTAL

Patients assigned to 1 of 9 possible dosing groups

Biological: ACE-041

Interventions

ACE-041BIOLOGICAL

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.

ACE-041

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Acceleron Investigative Site

Scottsdale, Arizona, United States

Location

Acceleron Investigative Site

Durham, North Carolina, United States

Location

Acceleron Investigative Site

Nashville, Tennessee, United States

Location

Acceleron Investigative Site

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

ALK1-Fc fusion protein, human

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2009

First Posted

October 16, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2012

Study Completion

October 1, 2012

Last Updated

March 18, 2013

Record last verified: 2013-03

Locations

US(4)