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

Acceleron Pharma

Status and phase

Completed

Phase 2

Conditions

Squamous Cell Carcinoma of the Head and Neck

Treatments

Biological: Dalantercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT01458392

dalantercept (Other Identifier)

A041-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.