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This study will determine the maximum tolerated dose, safety and pharmacokinetic profile of R4733 (RO4929097), administered orally to patients with refractory metastatic or locally advanced solid tumors. The study will assess three different dosing schedules; in one schedule R4733 will be administered 3days on/ 4 days off, in another on days 1-7 of each 21 day cycle, and in a third schedule continuously daily. The starting dose for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of the safety and tolerability of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is 100-200 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG4733 | Drug | Administered orally daily at ascending doses to successive cohorts of patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs, laboratory parameters. | Throughout study |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor assessments | day 15 cycle 1, at the end of cycle 2 and every 6 weeks thereafter | |
| Pharmacokinetic profile | After first dose and last dose (or day 15) of cycles 1 and 2 |
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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 |
|---|---|---|---|---|---|---|
| Aurora | Colorado | 80045 | United States | |||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C545185 | 2,2-dimethyl-N-(6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-N'-(2,2,3,3,3-pentafluoropropyl)malonamide |
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| RG4733 | Drug | Administered orally at ascending doses to successive cohorts of patients, on a 3 days on/ 4 days off schedule |
|
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| RG4733 | Drug | Administered orally at ascending doses to successive cohorts of patients, on days 1-7 of each 21 day cycle |
|
|
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Boston | Massachusetts | 02115 | United States |
| Boston | Massachusetts | 02215 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Houston | Texas | 77030 | United States |
| San Antonio | Texas | 98229 | United States |