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To determine the activity of SCH 727965 in participants with breast cancer and in participants with nonsmall-cell lung cancer (NSCLC) compared to standard treatment. The standard treatment used is capecitabine for breast cancer and erlotinib for NSCLC. The study will also determine the activity of SCH 727965 treatment in participants who experience cancer progression after standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 727965 | Drug | SCH 727965 50 mg/m^2 IV on Day 1 of each 21 day cycle until disease progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression. | Date of randomization to date of tumor progression. | Every 6 weeks for 30 weeks, and then every 9 weeks. Assessments continue until disease progression. |
| Overall response rate in participants treated with SCH 727965 after disease progression on the comparator drug. | Percentage of participants with tumor responses (partial responses + complete responses). | Every 6 weeks for 30 weeks, and then every 9 weeks. |
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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:
NSCLC: at least one, but no more than two prior chemotherapeutic regimens for advanced disease.
Measurable disease by the RECIST.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
Ability to swallow tablets.
Exclusion Criteria:
Known brain metastases. For NSCLC only, a participant with central nervous system metastasis is eligible provided the participant has received definitive local therapy (ie, radiation therapy or surgery), has stopped receiving treatment with corticosteroids, and is without symptoms for at least 4 weeks before randomization.
History of previous radiation therapy to >25% of total bone marrow.
Known HIV infection.
Known active hepatitis B or hepatitis C.
Previous treatment with SCH 727965 or other cyclin-dependent-kinase inhibitors.
BREAST CANCER:
NSCLC: previous treatment with erlotinib.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24393852 | Result | Mita MM, Joy AA, Mita A, Sankhala K, Jou YM, Zhang D, Statkevich P, Zhu Y, Yao SL, Small K, Bannerji R, Shapiro CL. Randomized phase II trial of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus capecitabine in patients with advanced breast cancer. Clin Breast Cancer. 2014 Jun;14(3):169-76. doi: 10.1016/j.clbc.2013.10.016. Epub 2013 Oct 26. | |
| 24388167 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C553669 | dinaciclib |
| D000069287 | Capecitabine |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| 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. |
|
|
| Stephenson JJ, Nemunaitis J, Joy AA, Martin JC, Jou YM, Zhang D, Statkevich P, Yao SL, Zhu Y, Zhou H, Small K, Bannerji R, Edelman MJ. Randomized phase 2 study of the cyclin-dependent kinase inhibitor dinaciclib (MK-7965) versus erlotinib in patients with non-small cell lung cancer. Lung Cancer. 2014 Feb;83(2):219-23. doi: 10.1016/j.lungcan.2013.11.020. Epub 2013 Dec 2. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |