Approval Probability
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Dinaciclib · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Dinaciclib | EXPERIMENTAL | - |
| Ofatumumab | ACTIVE_COMPARATOR | - |
| Dinaciclib + Rituximab | EXPERIMENTAL | Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13. |
| Name | Type | Description |
|---|---|---|
| Dinaciclib | DRUG | Dinaciclib administered intravenously over 2 hours at a dose of 7 mg/m\^2 on Day 1, 10 mg/m\^2 on Day 8, and 14 mg/m\^2 on Day 15 in Cycle 1. Starting in Cycle 2 and thereafter, dinaciclib will be dosed at 14 mg/m\^2 on Days 1, 8, and 15 of each 28-day cycle for a total of 12 cycles. |
| Ofatumumab | DRUG | Ofatumumab administered intravenously at a dose of 300 mg on Cycle 1 Day 1, followed by 2000 mg on Cycle 1 Days 8, 15, and 22; Cycle 2 Days 1, 8, 15, and 22; followed 5 weeks later on Day 1 of Cycles 4-12. |
| Rituximab | BIOLOGICAL | Rituximab 375 mg/m\^2 will be administered IV on Day 1, 8, 15 and 22 in Cycle 1 (28 day cycle) and on Day 1 in Cycles 3-13 (28 day cycles). |
Inclusion Criteria: * Aged 18 years or older * Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) * Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination re...
Dinaciclib is an investigational small molecule being studied for the treatment of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma. It is being developed by Merck & Company, Inc. (MRK) and is currently in clinical development, though it is not approved by the FDA.
Dinaciclib is a small molecule that targets cyclin-dependent kinases (CDKs), which are enzymes involved in cell cycle regulation. By inhibiting these kinases, it aims to disrupt the proliferation of cancer cells in conditions like Chronic Lymphocytic Leukemia.
Dinaciclib is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in clinical trials for oncology indications.
Dinaciclib is in Phase 1 clinical development. It has completed a Phase 1 trial in combination with rituximab for Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, and a Phase 3 trial comparing it to ofatumumab in refractory CLL has also been completed.
Dinaciclib has been studied in two completed trials: NCT01580228, a Phase 3 study comparing dinaciclib versus ofatumumab in patients with refractory Chronic Lymphocytic Leukemia, and NCT01650727, a Phase 1 study of dinaciclib in combination with rituximab in participants with CLL and Small Lymphocytic Lymphoma.
Dinaciclib is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied as a monotherapy and in combination with rituximab for the treatment of Chronic Lymphocytic Leukemia.