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| ID | Type | Description | Link |
|---|---|---|---|
| AZD0530 study 23 |
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This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD0530 + Paclitaxel |
|
| 2 | Experimental | AZD0530 + Carboplatin |
|
| 3 | Experimental | AZD0530 + Carboplatin + Paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0530 | Drug | oral tablet |
| |
| Carboplatin |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans. | Assessed at each visit |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm. | Assessed at each visit | |
| To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steinar Aamdal, MD | Radium Hospital, Norway | Principal Investigator |
| Mary Stuart, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Paris | France | ||||
| Research Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C515233 | saracatinib |
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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| Drug |
intravenous infusion |
|
| Paclitaxel | Drug | intravenous infusion |
|
| Assessment at end of study |
| To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters. | Predetermined timepoints after dose administration |
| Pierre-Bénite |
| France |
| Research Site | Amsterdam | Netherlands |
| Research Site | Groningen | Netherlands |
| Research Site | Oslo | Norway |
| Research Site | Glasgow | United Kingdom |
| Research Site | Sutton | United Kingdom |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |