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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate

Outcome Time Frame:

Assessed at 30 days after last dose of dalantercept, or up to approximately 5 months from initiation of treatment.

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

A041-03

NCT ID:

NCT01458392

Start Date:

October 2011

Completion Date:

August 2013

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Acceleron Investigative SiteSalt Lake City, Utah  
Acceleron Investigative SiteAurora, Colorado  
Acceleron Investigative SiteAtlanta, Georgia  
Acceleron Investigative SiteBoston, Massachusetts  
Acceleron Investigative SiteDetorit, Michigan  
Acceleron Investigative SiteNew York, New York  
Acceleron Investigative SitePhiladelphia, Pennsylvania  
Acceleron Investigative SiteSan Antonio, Texas