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This study will determine the maximum tolerated dose, and assess the safety, tolerability and pharmacokinetics of R1530 administered orally to patients with advanced or metastatic solid tumors. R1530 will be administered daily for 14 days at the starting dose; this dose will be escalated in subsequent cohorts of patients, after a satisfactory assessment of safety and tolerability of the previous dose, until the maximum tolerated dose is reached. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG1530 | Drug | Administered po at escalating doses (10 cohorts) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| AEs, laboratory parameters | Throughout study | |
| Plasma levels of R1530 | Throughout study | |
| Tumor assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | 02114-2696 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Every 2 cycles of treatment |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Boston | Massachusetts | 02215 | United States |
| Detroit | Michigan | 48201 | United States |
| Las Vegas | Nevada | 89135 | United States |
| Houston | Texas | 77030 | United States |