Phase 2
N=46
Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck
Squamous Cell Carcinoma of the Head and Neck
Bottom Line
View on ClinicalTrials.gov: NCT01458392 ↗Enrolled (actual)
46
Serious AEs
28.3%
Results posted
Jun 2017
Primary outcome: Primary: Objective Response Rate (ORR) — 0; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dalantercept (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) |
0; 2 | — |
| SECONDARY Safety and Tolerability |
2; 13; 31 | — |
| SECONDARY Dalantercept Serum Concentration After Single and Multiple Doses |
2446; 5336 | — |
| SECONDARY Dalantercept Serum Concentration After Single and Multiple Doses |
2446; 5336 | — |
| SECONDARY Progression Free Survival (PFS) |
5.8; 6.1 | — |
| SECONDARY Overall Survival (OS) |
30.9; 41.3 | — |
| SECONDARY Disease Control Rate |
30.8; 44.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01458392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.