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The study will evaluate the safety, tolerability, maximum administered dose, and dose limiting toxicity of SCH 727965 administered as an intravenous infusion on Days 1, 8 and 15 of each 28 day cycle in participants with solid tumors, non Hodgkins lymphoma, multiple myeloma or chronic lymphocytic leukemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 727965 | Drug | Dose escalation of SCH 727965 IV administered in 28-day cycles, on Days 1, 8, and 15 of each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of SCH 727965, including maximum administered dose and dose-limiting toxicity. | End of trial | |
| In participants with advanced solid tumors, non Hodgkin's lymphoma or multiple myeloma, pharmacodynamic effects of SCH 727965 with an ex vivo lymphocyte stimulation assay of participant's peripheral blood lymphocytes. | End of trial |
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Inclusion Criteria:
Age >=18 years, either sex, any race.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
There must be no known standard therapy, or disease must be refractory to standard therapy
Adequate hematologic, renal, and hepatic organ function and laboratory parameters
For advanced solid tumors, non-Hodgkin's lymphoma, or multiple myeloma:
Subjects with multiple myeloma must have measurable disease defined as:
Serum monoclonal protein greater than 0.5 g/dL or urine light chain excretion of greater than 0.2 g/24-hour obtained within 4 weeks prior to the start of treatment.
Participants with lower M protein values or nonsecretory myeloma are eligible if measurable disease can be established within 4 weeks prior to start of treatment, such as:
For B-cell chronic lymphocytic leukemia (B-CLL):
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25708835 | Background | Flynn J, Jones J, Johnson AJ, Andritsos L, Maddocks K, Jaglowski S, Hessler J, Grever MR, Im E, Zhou H, Zhu Y, Zhang D, Small K, Bannerji R, Byrd JC. Dinaciclib is a novel cyclin-dependent kinase inhibitor with significant clinical activity in relapsed and refractory chronic lymphocytic leukemia. Leukemia. 2015 Jul;29(7):1524-9. doi: 10.1038/leu.2015.31. Epub 2015 Feb 24. | |
| 24131779 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C553669 | dinaciclib |
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| Result |
| Nemunaitis JJ, Small KA, Kirschmeier P, Zhang D, Zhu Y, Jou YM, Statkevich P, Yao SL, Bannerji R. A first-in-human, phase 1, dose-escalation study of dinaciclib, a novel cyclin-dependent kinase inhibitor, administered weekly in subjects with advanced malignancies. J Transl Med. 2013 Oct 16;11:259. doi: 10.1186/1479-5876-11-259. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |