Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dinaciclib, MK-7965
SCH 727965 · 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...
SCH 727965 is an investigational small molecule being studied in oncology for the treatment of breast neoplasms and solid tumors. It has also been evaluated in clinical trials involving non-small-cell lung cancer, lymphoma, multiple myeloma, and chronic lymphocytic leukemia. It is not an approved therapy and remains in clinical development.
SCH 727965 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck sponsored the clinical studies of the compound, including the Phase 1 and Phase 2 trials conducted in patients with advanced cancer.
SCH 727965 has reached Phase 2 in its clinical development program. Two completed Phase 1 trials evaluated every-3-week and weekly dosing schedules in advanced cancer, and a completed Phase 2 trial studied the drug in patients with advanced breast and lung cancers.
SCH 727965 has been studied in three completed trials. NCT00871910 was a Phase 1 every-3-week dosing study in advanced cancer, NCT00871663 was a Phase 1 weekly dosing study, and NCT00732810 was a Phase 2 study in advanced breast and lung cancers. All three trials have completed.
Across the three completed trials, 301 patients were enrolled in studies of SCH 727965. The Phase 1 every-3-week dosing trial enrolled 81 patients, the Phase 1 weekly dosing trial enrolled 123 patients, and the Phase 2 breast and lung cancer trial enrolled 97 patients.
Yes, the clinical development program for SCH 727965 included biomarker-selected patient populations. The Phase 2 trial in advanced breast and lung cancers was active-controlled and randomized, reflecting an effort to evaluate the drug in defined patient groups rather than an unselected population.