Status:
COMPLETED
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 preven...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01458392
Start Date
October 1 2011
End Date
September 1 2015
Last Update
October 5 2022
Active Locations (8)
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1
Acceleron Investigative Site
Aurora, Colorado, United States
2
Acceleron Investigative Site
Atlanta, Georgia, United States
3
Acceleron Investigative Site
Boston, Massachusetts, United States
4
Acceleron Investigative Site
Detroit, Michigan, United States