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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458392
First Posted: October 24, 2011
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Acceleron Pharma, Inc.
  Purpose
Dalantercept, a soluble form of the activin receptor-like kinase-1 protein, is being studied in patients with squamous cell carcinoma of the head and neck (SCCHN). Dalantercept blocks the development of blood vessels that supply tumors.

Condition Intervention Phase
Squamous Cell Carcinoma of the Head and Neck Biological: Dalantercept Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 (ORR) [ Time Frame: Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. ]
    ORR is defined as the proportion of patients who met criteria for complete response or partial response. Patients were evaluable for ORR if they had at least one measurable lesion at baseline and at least one disease assessment after baseline. RECIST version 1.1 was used to evaluate efficacy. In addition, patients who developed clinical or radiological progression of disease prior to the scheduled tumor assessment were also considered evaluable for response. The response rate was estimated as the proportion of patients evaluable for response who meet the criteria for complete (CR) and partial response (PR). Per RECIST v1.1 for target lesions and assessed by MRI: complete response (CR), disappearance of all target lesions; partial response (PR), >=30% decrease in the sum of the longest diameter of target lesions; overall response (OR) = CR + PR.


Secondary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept. ]
    Number of participants with at least one adverse event as a measure of safety and tolerability.

  • Dalantercept Serum Concentration After Single and Multiple Doses [ Time Frame: Up to 43 days from initiation of treatment. ]
    Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is AUC0-t (cycle 1).

  • Dalantercept Serum Concentration After Single and Multiple Doses [ Time Frame: Up to 43 days from initiation of treatment. ]
    Pharmacokinetic samples were collected pre- and post- dose on Days: 1, 8, 15, 22, 29, and 43. Reported below is Cmax (cycle 1).

  • Progression Free Survival (PFS) [ Time Frame: Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. ]
    PFS is defined as the date of the first dose to the first observation of disease progression (according to RECIST v.1.1) or death due to any cause. Progression is defined using RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  • Overall Survival (OS) [ Time Frame: Survival captured until death or at a minimum 1 year from first dose of dalantercept. ]
    OS is calculated as the number of months from date of the first dose to the date of death. The last patient treated will be followed for overall survival for 1 year following treatment initiation.

  • Disease Control Rate [ Time Frame: Tumor assessments performed every 6 weeks, up to 30 days after the last dose of dalantercept and/or disease progression, up to approximately 2 years. ]
    Disease control rate will be estimated as the proportion of patients evaluable for response who meet the criteria for complete response, partial response, or stable disease.


Enrollment: 46
Study Start Date: October 2011
Study Completion Date: September 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dalantercept
dalantercept
Biological: Dalantercept
Subcutaneous dose of dalantercept once every 3 weeks.

Detailed Description:
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 SCCHN tumors to shrink or stop growing. This study will also evaluate the safety of dalantercept in patients with SCCHN.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Detroit, 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

Responsible Party: Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01458392     History of Changes
Other Study ID Numbers: A041-03
dalantercept ( Other Identifier: USAN )
First Submitted: October 20, 2011
First Posted: October 24, 2011
Results First Submitted: April 11, 2017
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: May 2017

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
Immunoglobulin Fc Fragments
Immunologic Factors
Physiological Effects of Drugs