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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006252-36 | EudraCT Number |
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This multi-center, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with cytarabine in patients with acute myelogenous leukemia. In Arm A, cohorts of previously untreated patients deemed unsuitable for standard induction therapy will receive escalating oral doses of RO5045377 and cytarabine 20 mg/m2 subcutaneously daily for Days 1 to 10 of each 28-day cycle. In Arm B, cohorts of patients who have relapsed or are refractory after at least one cytarabine/anthracycline containing regimen will receive escalating oral doses of RO5045377 on Days 1 to 5 and cytarabine 1 gm/m2 intravenously on Days 1 to 6 of each 28-day cycle. Patients will receive up to 4 cycles of therapy, patients in Arm A who achieve hematologic response may continue additional cycles until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Previously untreated | Experimental |
| |
| B: Relapse/Refractory | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5045377 | Drug | Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose/dose-limiting toxicities | approximately 12 months | |
| Safety: Incidence of adverse events | approximately 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Hematologic response | approximately 1 year | |
| Pharmacodynamics: Biomarkers (MIC-1, protein, nucleic acid, other) from bone marrow/buccal tissue/blood | Pre-dose (and up to 12 hours post-dose Day 1 and Day 10 or Day 5) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valhalla | New York | 10595 | United States | |||
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| RO5045377 | Drug | Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle |
|
| cytarabine | Drug | 20 mg/m2 sc, Days 1 to 10 of each 28-day cycle |
|
| cytarabine | Drug | 1 gm/m2 iv, Days 1 to 6 of each 28-day cycle |
|
| Pharmacokinetics: Cmax/area under the concentration-time curve | Pre-dose and up to 12 hours post-dose Day 1 and Day 10 or Day 5 |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| San Antonio | Texas | 78229 | United States |
| Toronto | Ontario | M5G 2M9 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Marseille | 13273 | France |
| Bologna | Emilia-Romagna | 40138 | Italy |
| Glasgow | G12 0YN | United Kingdom |
| Manchester | M204BX | United Kingdom |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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