Clinical trial NCT01458392: Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
Sponsor class: INDUSTRY
First posted: 2011-10-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 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 outcomes:
measure: Safety and Tolerability
timeFrame: Adverse events captured from first dose of dalantercept through 30 days after last dose of dalantercept.
measure: Dalantercept Serum Concentration After Single and Multiple Doses
timeFrame: Up to 43 days from initiation of treatment.
measure: Dalantercept Serum Concentration After Single and Multiple Doses
timeFrame: Up to 43 days from initiation of treatment.
measure: Progression Free Survival (PFS)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: Survival captured until death or at a minimum 1 year from first dose of dalantercept.
measure: Disease Control Rate
timeFrame: 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.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Acceleron Investigative Site
state: Colorado
city: Atlanta
country: United States
facility: Acceleron Investigative Site
state: Georgia
city: Boston
country: United States
facility: Acceleron Investigative Site
state: Massachusetts
city: Detroit
country: United States
facility: Acceleron Investigative Site
state: Michigan
city: New York
country: United States
facility: Acceleron Investigative Site
state: New York
city: Philadelphia
country: United States
facility: Acceleron Investigative Site
state: Pennsylvania
city: San Antonio
country: United States
facility: Acceleron Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Acceleron Investigative Site
state: Utah
Study officials:
References: