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

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.
 
ClinicalTrials.gov Identifier: NCT01458392
Recruitment Status : Completed
First Posted : October 24, 2011
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Acceleron Pharma Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Biological: Dalantercept Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
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
Study Start Date : October 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dalantercept
dalantercept
 Biological: Dalantercept
Subcutaneous dose of dalantercept once every 3 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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).

  3. 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).

  4. 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.

  5. 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.

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Responsible Party: Acceleron Pharma Inc.
ClinicalTrials.gov Identifier: NCT01458392    
Other Study ID Numbers: A041-03
dalantercept ( Other Identifier: USAN )
First Posted: October 24, 2011    Key Record Dates
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site