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

September 13, 2022 updated by: Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

An Open-label Phase 2 Study of Dalantercept in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States
        • Acceleron Investigative Site
    • Georgia
      • Atlanta, Georgia, United States
        • Acceleron Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States
        • Acceleron Investigative Site
    • Michigan
      • Detroit, Michigan, United States
        • Acceleron Investigative Site
    • New York
      • New York, New York, United States
        • Acceleron Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Acceleron Investigative Site
    • Texas
      • San Antonio, Texas, United States
        • Acceleron Investigative Site
    • Utah
      • Salt Lake City, Utah, United States
        • Acceleron Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dalantercept
dalantercept
Biological: Dalantercept
Subcutaneous dose of dalantercept once every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.
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).
Up to 43 days from initiation of treatment.
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).
Up to 43 days from initiation of treatment.
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.
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.
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.
Survival captured until death or at a minimum 1 year from first dose of dalantercept.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 21, 2011

First Posted (Estimate)

October 24, 2011

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A041-03
  • dalantercept (Other Identifier: USAN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Squamous Cell Carcinoma of the Head and Neck

Clinical Trials on Dalantercept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe