Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT01458392
First received: October 20, 2011
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

For cancer cells to grow, they need to have nutrients supplied to them through blood vessels. The study drug, dalantercept, 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 dalantercept 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 dalantercept in patients with SCCHN.


Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck
Biological: Dalantercept
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 Dalantercept 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 dalantercept, 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 dalantercept, or up to approximately 5 months from initiation of treatment. ] [ Designated as safety issue: Yes ]
  • Dalantercept 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 dalantercept, 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 dalantercept, 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 dalantercept, 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 dalantercept, 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 dalantercept, 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: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dalantercept Biological: Dalantercept
Subcutaneous dose of dalantercept 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 or contraindicated for treatment with a platinum containing therapy. (Note: platinum therapy can occur upfront or after recurrence of disease. Failure of platinum therapy is not required.)
  • 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 for which chemotherapy or other anti-cancer therapy is indicated.
  • Chemotherapy or other anti-cancer therapy or radiation therapy 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.
  • 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 4 weeks prior to study day 1 (patients must have recovered completely from any previous surgery 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458392

Locations
United States, Colorado
Acceleron Investigative Site
Aurora, Colorado, United States
United States, Georgia
Acceleron Investigative Site
Atlanta, Georgia, United States
United States, Massachusetts
Acceleron Investigative Site
Boston, Massachusetts, United States
United States, Michigan
Acceleron Investigative Site
Detorit, Michigan, United States
United States, New York
Acceleron Investigative Site
New York, New York, United States
United States, Pennsylvania
Acceleron Investigative Site
Philadelphia, Pennsylvania, United States
United States, Texas
Acceleron Investigative Site
San Antonio, Texas, United States
United States, Utah
Acceleron Investigative Site
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: December 27, 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 July 24, 2014