Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SCH 727965, MK-7965
Dinaciclib · 5 trials · 9 indications
Date of randomization to date of tumor progression.
Percentage of participants with tumor responses (partial responses + complete responses).
| Arm | Type | Description |
|---|---|---|
| Dinaciclib | EXPERIMENTAL | - |
| Ofatumumab | ACTIVE_COMPARATOR | - |
| Breast cancer randomized to SCH 727965 | EXPERIMENTAL | - |
| Breast cancer randomized to capecitabine | ACTIVE_COMPARATOR | - |
| SCH 727965 in breast cancer after progression on capecitabine | EXPERIMENTAL | - |
| NSCLC randomized to SCH 727965 | EXPERIMENTAL | Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 |
| NSCLC randomized to erlotinib | ACTIVE_COMPARATOR | Note: Enrollment of participants with NSCLC was completed per protocol as of 26 JAN 2010 |
| SCH 727965 in NSCLC after progression on erlotinib | EXPERIMENTAL | Note: Crossover to SCH 727965 after progression on erlotinib was completed per protocol as of 26 JAN 2010 |
| Dinaciclib + Rituximab | EXPERIMENTAL | Rituximab will be administered in Cycles 1 and 3-13. Dinaciclib will be administered in Cycles 2-13. |
| 2 Hour SCH 727965 infusion | EXPERIMENTAL | Participants treated with 2 hour SCH 727965 IV infusion |
| 8 Hour SCH 727965 infusion | EXPERIMENTAL | Participants treated with 8 hour SCH 727965 IV infusion. |
| 24 Hour SCH 727965 infusion | EXPERIMENTAL | Participants treated with 24 hour SCH 727965 IV infusion. |
| 2 Hour SCH 727965 infusions plus aprepitant in Cycle 1 | EXPERIMENTAL | Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 1 only. |
| 2 Hour SCH 727965 infusion plus aprepitant in Cycle 2 | EXPERIMENTAL | Participants randomized to 2 Hour SCH 727965 infusion, plus concomitant ondansetron and dexamethasone in Cycles 1 and 2, and aprepitant in Cycle 2 only. |
| Advanced solid tumors | EXPERIMENTAL | Participants with advanced solid tumors treated with SCH 727965 in dose-escalation cohorts |
| Non-Hodgkin's lymphoma and multiple myeloma | EXPERIMENTAL | Participants with non-Hodgkin's lymphoma or multiple myeloma treated with SCH 727965 |
| B cell chronic lymphocytic leukemia | EXPERIMENTAL | Participants with B-cell chronic lymphocytic leukemia treated with SCH 727965 in dose-escalation cohorts |
| 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. |
| SCH 727965 | DRUG | SCH 727965 50 mg/m\^2 IV on Day 1 of each 21 day cycle until disease progression. |
| Capecitabine | DRUG | Capecitabine 1250 mg/m\^2 orally twice daily from Day 1 to Day 14 of each 21 day cycle until disease progression. |
| Erlotinib | DRUG | Erlotinib 150 mg orally once daily until disease progression. |
| 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). |
| Aprepitant | DRUG | Oral aprepitant in Cycle 1 or Cycle 2, depending on the study arm: 125 mg 1 hour prior to the SCH 727965 infusion on Day 1, and 80 mg on Days 2 and 3. |
| Ondansetron | DRUG | Ondansetron 32 mg IV 30 minutes prior to the SCH 727965 infusion on Day 1 of Cycles 1 and 2. |
| Dexamethasone | DRUG | Oral dexamethasone in Cycles 1 and 2: 12 mg 30 minutes prior to the SCH 727965 infusion on Day 1, and 8 mg in the morning on Days 2, 3, and 4. |
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 developed by Merck & Company, Inc. (MRK) for the treatment of chronic lymphocytic leukemia, a cancer of the blood and bone marrow. It has been studied in clinical trials, including a Phase 3 study in patients with refractory chronic lymphocytic leukemia.
Dinaciclib targets CDK2, CDK9, CDK1, and CDK5, which are cyclin-dependent kinases involved in regulating cell division and transcription. It acts as an inhibitor of these kinases. By inhibiting CDK2, CDK9, CDK1, and CDK5, dinaciclib is designed to interfere with processes that support cancer cell growth and survival.
Dinaciclib is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is the sponsor of the clinical trials evaluating dinaciclib in chronic lymphocytic leukemia and small lymphocytic lymphoma.
Dinaciclib has been evaluated in Phase 3 clinical development. A Phase 3 study compared dinaciclib versus ofatumumab in patients with refractory chronic lymphocytic leukemia. The drug is investigational and has not been approved by the FDA for any indication.
Dinaciclib has been studied in two completed clinical trials. NCT01580228 was a Phase 3 study comparing dinaciclib versus ofatumumab in patients with refractory chronic lymphocytic leukemia, enrolling 44 participants. NCT01650727 was a Phase 1 study of dinaciclib in combination with rituximab in participants with chronic lymphocytic leukemia and small lymphocytic lymphoma, enrolling 5 participants.
Dinaciclib has been studied as a treatment for chronic lymphocytic leukemia, including the refractory setting. One trial evaluated it in combination with rituximab in chronic lymphocytic leukemia and small lymphocytic lymphoma, and a Phase 3 trial compared it with ofatumumab in refractory chronic lymphocytic leukemia. It remains investigational for this use.