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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003408-19 | EudraCT Number |
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Study terminated for business reasons
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The aim of part 1 of this study is to determine the optimal biological dose (OBD) and maximum tolerated dose (MTD) for WX-554 and the recommended dose/dose schedules for the chronic treatment in part 2. The aim of part 2 is to further determine the safety and tolerability of chronic treatment with WX-554.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WX-554 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WX-554 | Drug | Capsules of WX-554 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Determination of the Optimal Biological Dose (OBD) by the assessment of ERK phosphorylation (pERK) in peripheral blood mononuclear cells (PBMC) and assessment of TNF-alpha in plasma. | Cycle 1 (21 days) | |
| Part 1: Determination of the Maximum Tolerated Dose (MTD) for WX-554 by the evaluation of DLTs in 3-6 patients at the end of 1 treatment cycle | Cycle 1 (21 days) | |
| Part 2: To further determine the safety and tolerability by evaluating the incidence and severity of adverse events and serious adverse events (as per CTCAE grading), changes in hematology and chemistry values, vital signs, ECGs. | expected average of 3-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of PK variables maximum observed concentration (Cmax), minimum observed concentration (Cmin), time at which Cmax was present (tmax), Area Under Curve (AUC) | PK profile on day 1 and day 8 | |
| Assessment of ERK phosphorylation (pERK) in PBMC and tissue, assessment of TNF-alpha in plasma after oral intake of the OBD/MTD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Plummer, MD | Sir Bobby Robson Cancer Trials Research Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University Belfast Cancer Centre | Belfast | BT9 7AB | United Kingdom | |||
| Beatson West of Scotland Cancer Centre |
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| expected average of 3-6 months |
| Tumour response evaluation using RECIST 1.1 | expected average of 3-6 months |
| Glasgow |
| G12 0YN |
| United Kingdom |
| St James' Institute of Oncology | Leeds | LS9 7TF | United Kingdom |
| Christie NHS Foundation Trust, Oak Road Treatment Centre | Manchester | M20 4BX | United Kingdom |
| Sir Bobby Robson Cancer Trials Research Centre | Newcastle upon Tyne | NE7 7DN | United Kingdom |