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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002606-19 |
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The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | The study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8055 | Drug | Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD8055 | Assessed at all visits |
| Measure | Description | Time Frame |
|---|---|---|
| To identify early signals of anti-tumour activity | Visits 1, 5, and 9 and 11 | |
| To identify early signals of anti-tumor activity | Visits 1, 5, 9 and 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof Stan Kaye | Royal Marsden Hospital, Sutton, Surrey, England, SM2 5PT | Principal Investigator |
| Dr Carol Aghajanian | Memorial Sloan-Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065, USA | Principal Investigator |
| Dr Aung Naing | MD Anderson Cancer Centre, 1515 Holcombe Blvd, Houston, Texas, USA | Principal Investigator |
| Professor Eric Raymond | Hôpital Beaujon, 100, Boulevard du Général Leclerc, 92118 Clichy Cedex, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | New York | New York | 10065 | United States | ||
| Research Site |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C546624 | (5-(2,4-bis((3S)-3-methylmorpholin-4-yl)pyrido(2,3-d)pyrimidin-7-yl)-2-methoxyphenyl)methanol |
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| Houston |
| Texas |
| United States |
| Research Site | Clichy | France |
| Research Site | Sutton | Surrey | United Kingdom |