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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01379534 | A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer | PHASE2 | COMPLETED | 53 | — | — | Nov 1, 2011 | Mar 1, 2014 | May 20, 2015 | 45 | United States, Brazil +5 |
The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| TKI258 | EXPERIMENTAL | 1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status |
| Name | Type | Description |
|---|---|---|
| TKI258 | DRUG | - |
Inclusion Criteria: * Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy) * Female patients ≥ 18 years old * Documented radiologically confirmed progression of disease after p...