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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00806156 | Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer | PHASE2 | COMPLETED | 178 | — | — | Oct 1, 2008 | Jan 1, 2013 | Jul 12, 2021 | 20 | United States, Belgium +1 |
The ORR was defined as the proportion of patients with a complete response (CR) or a partial response (PR) per RECIST 1.0 based upon the best response as assessed by the Investigator. CR was defined by RECIST 1.1 as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have had reduction in short axis to \<10 mm. PR was defined by RECIST 1.1 as at least a 30% decrease in the sum of the diameters (SOD) of target lesions, taking as reference the baseline SOD. The analysis was performed for patients in the Primary Efficacy Population.
| Arm | Type | Description |
|---|---|---|
| NKTR-102 q14d | EXPERIMENTAL | NKTR-102 was administered as an intravenous (IV) infusion over 90 ± 10 minutes, on Day 1 of each 2-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 4 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients. |
| NKTR-102 q21d | EXPERIMENTAL | NKTR-102 was administered as an IV infusion over 90 ± 10 minutes, on Day 1 of each 3-week \[± 2 days\] cycle at a dose of 170 mg/m\^2 for the first 6 patients enrolled and at a dose of 145 mg/m\^2 for the remainder of the patients. |
| Name | Type | Description |
|---|---|---|
| NKTR-102 q14d | DRUG | NKTR-102 given on a q14 day schedule |
| NKTR-102 q21d | DRUG | NKTR-102 given on a q21 day schedule |
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer 2. Inoperable metastatic or locally advanced ovarian cancer 3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 mont...