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

NCT01458392 | Completed Phase 2 Results DMC

• 2 other identifiers: A041-03dalantercept
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 8

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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 Outcomes (6)

• 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

  Up to 43 days from initiation of treatment.

• Dalantercept Serum Concentration After Single and Multiple Doses

  Up to 43 days from initiation of treatment.

• Progression Free Survival (PFS)

  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)

  Survival captured until death or at a minimum 1 year from first dose of dalantercept.

Study Arms (1)

Dalantercept

EXPERIMENTAL

dalantercept

Biological: Dalantercept

Interventions

Dalantercept BIOLOGICAL

Subcutaneous dose of dalantercept once every 3 weeks.

Dalantercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA: lead

Study Sites (8)

Acceleron Investigative Site

Aurora, Colorado, United States

Location

Acceleron Investigative Site

Atlanta, Georgia, United States

Location

Acceleron Investigative Site

Boston, Massachusetts, United States

Location

Acceleron Investigative Site

Detroit, Michigan, United States

Location

Acceleron Investigative Site

New York, New York, United States

Location

Acceleron Investigative Site

Philadelphia, Pennsylvania, United States

Location

Acceleron Investigative Site

San Antonio, Texas, United States

Location

Acceleron Investigative Site

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

ALK1-Fc fusion protein, human

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 24, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 5, 2022
• Results First Posted: June 27, 2017

Record last verified: 2022-09

Locations

US (8)