Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01458392 | Study of Dalantercept in Patients With Squamous Cell Carcinoma of the Head and Neck | PHASE2 | COMPLETED | 46 | — | — | Oct 1, 2011 | Sep 1, 2015 | Oct 5, 2022 | 8 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Dalantercept | EXPERIMENTAL | dalantercept |
| Name | Type | Description |
|---|---|---|
| Dalantercept | BIOLOGICAL | Subcutaneous dose of dalantercept once every 3 weeks. |
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 presu...