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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01861496 | Phase I/II Study to Evaluate the Safety and Tolerability of LiPlaCis in Patients With Advanced or Refractory Tumours | PHASE1 | COMPLETED | 50 | — | — | Apr 1, 2013 | Oct 1, 2021 | Feb 24, 2022 | 4 | Denmark |
Primary Objective: Assessment of adverse events and laboratory abnormalities
| Arm | Type | Description |
|---|---|---|
| LiPlaCis | EXPERIMENTAL | Dose escalation of LiPlaCis - a liposomal formulation of cisplatin will be administered intravenously in cycles every 3 weeks on day 1, day 8. Upon the investigator's judgement the patient may continue treatment for more than 3 cycles when benefiting from the study drug. |
| Name | Type | Description |
|---|---|---|
| LiPlaCis | DRUG | LiPlaCis IV every 3 weeks on day 1, day 8 |
Inclusion Criteria: * Histological or cytological documented locally advanced or metastatic solid tumour relapsed on 2 or more different prior therapies. From step 5 and extension phase, population limited to Skin Cancer patients (non screened) or metastatic Breast Cancer patients or metastatic cas...