Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SCH 727965 · 3 trials · 6 indications
Date of randomization to date of tumor progression.
Percentage of participants with tumor responses (partial responses + complete responses).
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
|---|---|---|
| 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. |
| 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: * Age \>=18 years, either sex, any race. * Histologically or cytologically confirmed breast cancer or NSCLC; and radiographic or clinically advanced disease. * BREAST CANCER: * participant must have previously received both a taxane and an anthracycline (unless anthracycline ...
SCH 727965 is an investigational small molecule being studied in oncology for the treatment of breast neoplasms and solid tumors. It has been evaluated in clinical trials for advanced breast and lung cancers, as well as other advanced solid tumors and hematologic malignancies. The drug is not approved and remains in clinical development.
SCH 727965 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company has sponsored clinical trials of the drug in patients with advanced cancers, including breast cancer and solid tumors.
SCH 727965 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in patients with advanced breast and lung cancers. The drug is investigational and not FDA approved, with no active trials currently listed.
SCH 727965 has been studied in three completed trials: NCT00732810, a Phase 2 study in advanced breast and lung cancers; NCT00871663, a Phase 1 weekly dosing study in advanced cancers; and NCT00871910, a Phase 1 every-3-week dosing study in advanced cancers. All trials are completed.
SCH 727965 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials. The drug remains in clinical development and has not received regulatory approval for any indication.