Trial record 2 of 4 for:
ace-041
Study of ACE-041 in Patients With Squamous Cell Carcinoma of the Head and Neck
This study is currently recruiting participants.
Verified May 2013 by Acceleron Pharma, Inc.
Sponsor:
Acceleron Pharma, Inc.
Information provided by (Responsible Party):
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01458392
First received: October 20, 2011
Last updated: May 3, 2013
Last verified: May 2013
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Purpose
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 find out if ACE-041 can cause squamous cell carcinoma of the head and neck (SCCHN) tumors to shrink or stop growing. This study will also evaluate the safety of ACE-041 in patients with SCCHN.
| Condition | Intervention | Phase |
|---|---|---|
|
Squamous Cell Carcinoma of the Head and Neck |
Biological: ACE-041 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Phase 2 Study of ACE-041 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
Resource links provided by NLM:
Further study details as provided by Acceleron Pharma, Inc.:
Primary Outcome Measures:
- Objective response rate [ Time Frame: Assessed at 30 days after last dose of ACE-041, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of participants with Adverse Events as a measure of safety and tolerability. [ Time Frame: Assessed at 30 days after last dose of ACE-041, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: Yes ]
- ACE-041 serum concentration after single and multiple doses. [ Time Frame: Up to 43 days from initiation of treatment. ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Assessed at 30 days after last dose of ACE-041, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Estimated to be assessed at approximately 1 year from initiation of treatment. ] [ Designated as safety issue: No ]
- Time to tumor progression [ Time Frame: Assessed at 30 days after last dose of ACE-041, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Assessed at 30 days after last dose of ACE-041, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: No ]
- Disease control rate [ Time Frame: Assessed at 30 days after last dose of ACE-041, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: No ]
- Expression of ALK1 in tumor tissue and blood [ Time Frame: Assessed at 30 days after last dose of ACE-041, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: ACE-041 |
Biological: ACE-041
Subcutaneous dose of ACE-041 once every 3 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Histologically and/or cytologically confirmed, recurrent or metastatic SCCHN of mucosal origin (oral cavity, oropharynx, hypopharynx or larynx) not amenable to further local therapy (surgery, or radiation including re-irradiation); patients with unknown primary SCCHN presumed to be of head and neck mucosal origin are eligible if they meet all other entry criteria.
- Previously treated with at least one platinum-containing regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key Exclusion Criteria:
- Nasopharyngeal carcinoma, paranasal sinus, salivary gland or primary skin SCCHN.
- Any other active malignancy.
- Chemotherapy or other anti-cancer therapy or radiation therapy within 3 weeks prior to study day 1.
- Treatment with another investigational drug or device, or approved therapy for investigational use, within 5 times the half-life of the drug or within 3 weeks prior to study day 1 if the half-life is not known.
- Major surgery within 6 weeks prior to study day 1.
- Clinically significant cardiovascular risk.
- Clinically significant active pulmonary risk.
- Clinically significant active bleeding.
- Peripheral edema ≥ Grade 1 within 4 weeks prior to study day 1.
- Pregnant or lactating female patients.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458392
Contacts
| Contact: Trial Manager | clinicaltrials@acceleronpharma.com |
Locations
| United States, Colorado | |
| Acceleron Investigative Site | Recruiting |
| Aurora, Colorado, United States | |
| United States, Georgia | |
| Acceleron Investigative Site | Recruiting |
| Atlanta, Georgia, United States | |
| United States, Massachusetts | |
| Acceleron Investigative Site | Recruiting |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Acceleron Investigative Site | Recruiting |
| Detorit, Michigan, United States | |
| United States, New York | |
| Acceleron Investigative Site | Recruiting |
| New York, New York, United States | |
| United States, Pennsylvania | |
| Acceleron Investigative Site | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| Acceleron Investigative Site | Recruiting |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Acceleron Investigative Site | Recruiting |
| Salt Lake City, Utah, United States | |
Sponsors and Collaborators
Acceleron Pharma, Inc.
More Information
No publications provided
| Responsible Party: | Acceleron Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT01458392 History of Changes |
| Other Study ID Numbers: | A041-03, dalantercept |
| Study First Received: | October 20, 2011 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 16, 2013