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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00113334 | Study of ABT-510 (Thrombospondin Analogue) in Patients With Advanced Head and Neck Cancer | PHASE1 | COMPLETED | 6 | — | — | Apr 1, 2005 | Mar 1, 2008 | Aug 7, 2014 | 1 | United States |
Response rate defined as percentage of number of complete response or partial response in total number of participants treated. Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1/\> new lesions; Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD, reference smallest sum LD. Trial conducted by Simon's optimal two-stage design and response rate estimated accordingly. For status of PR or CR, changes in tumor measurements confirmed by repeat assessments performed at 6 weeks, no less than 4 weeks after criteria for response is first met.
| Arm | Type | Description |
|---|---|---|
| ABT-510 (Thrombospondin) | EXPERIMENTAL | Fixed dose level of thrombospondin 100 mg subcutaneously twice daily. |
| Name | Type | Description |
|---|---|---|
| ABT-510 | DRUG | 100 mg subcutaneously twice daily |
Inclusion Criteria: * Patient has histologically proven squamous cell carcinoma of the head and neck that is not amenable to curative therapy, including radiation or surgery (including surgery following induction chemotherapy or chemo-radiation). * Patient's tumor is biopsy accessible. * Patient ha...