Dinaciclib has been evaluated across multiple clinical trials spanning Phase I through Phase III targeting diverse hematologic malignancies and advanced solid neoplasms. Sponsored by academic investigators, government organizations such as the National Cancer Institute, and pharmaceutical companies including Merck Sharp & Dohme and AbbVie, these studies assess dinaciclib as both monotherapy and in combination regimens. Trial statuses range from completed studies involving agents like epirubicin or bortezomib to active non-recruiting protocols and terminated combination evaluations with venetoclax.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01434316 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2011-11-11 | PHASE1 |
| NCT03484520 | TERMINATED | Cancer - Acute Myeloid Leukemia |
AbbVie |
2018-07-23 | PHASE1 |
| NCT01676753 | COMPLETED | Advanced or Metastatic Breast Cancer; Triple Negative Breast Cancer |
Jo Chien |
2016-12-28 | PHASE1 |
| NCT02684617 | TERMINATED | rrCLL; rrMM; rrDLBCL |
Merck Sharp & Dohme LLC |
2016-03-29 | PHASE1 |
| NCT03484520 | Terminated | Cancer - Acute Myeloid Leukemia |
AbbVie|Merck Sharp & Dohme LLC |
2018-07-23 | Phase 1 |
| NCT01711528 | COMPLETED | Recurrent Plasma Cell Myeloma |
National Cancer Institute (NCI) |
2012-12-19 | PHASE1 |
| NCT01783171 | COMPLETED | Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IV Pancreatic Cancer AJCC v6 and v7; Unresectable Pancreatic Carcinoma |
National Cancer Institute (NCI) |
2013-01-15 | PHASE1 |
| NCT01515176 | COMPLETED | Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia |
National Cancer Institute (NCI) |
2012-01 | PHASE1; PHASE2 |
| NCT01580228 | COMPLETED | Chronic Lymphocytic Leukemia (CLL) |
Merck Sharp & Dohme LLC |
2012-08 | PHASE3 |
| NCT01026324 | TERMINATED | Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma |
National Cancer Institute (NCI) |
2009-09 | PHASE1; PHASE2 |
| NCT00937937 | ACTIVE_NOT_RECRUITING | Acral Lentiginous Melanoma; Cutaneous Nodular Melanoma; Lentigo Maligna Melanoma; Low-CSD Melanoma; Mucosal Melanoma; Recurrent Melanoma; Stage IV Cutaneous Melanoma AJCC v6 and v7 |
National Cancer Institute (NCI) |
2009-07-01 | PHASE2 |
| NCT01650727 | COMPLETED | Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma |
Merck Sharp & Dohme LLC |
2012-10 | PHASE1 |
| NCT01624441 | COMPLETED | Estrogen Receptor Negative; HER2/Neu Negative; Male Breast Carcinoma; Progesterone Receptor Negative; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7; Triple-Negative Breast Carcinoma |
National Cancer Institute (NCI) |
2012-08-21 | PHASE1 |
| NCT01096342 | COMPLETED | Refractory Multiple Myeloma |
National Cancer Institute (NCI) |
2009-07 | PHASE2 |
| NCT01434316 | Active not recruiting | Advanced Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2011-11-01 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-08-03)
Check the
Dinaciclib (SCH 727965)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
- Dinaciclib (SCH 727965) Mechanism of Action: CDK9 Inhibition in Leukemic Cell Research
- Dinaciclib (SCH 727965): Selectivity & Specificity
- Dinaciclib (SCH 727965) Working Concentration | Cell Culture | Treatment
- Dinaciclib (SCH 727965) Solubility in DMSO
- Dinaciclib (SCH 727965) Stock Solution
- Dinaciclib (SCH 727965) Storage
- Dinaciclib (SCH 727965) Stability
- Dinaciclib (SCH 727965) Combination Database
- Dinaciclib (SCH 727965) Molecular Weight
- Dinaciclib (SCH 727965) SMILES
- Dinaciclib (SCH 727965) CAS Number
- Dinaciclib (SCH 727965) Chemical Structure (2D and 3D)
- Dinaciclib (SCH 727965) IC50 for Cell-based and Cell-free Assays
- Dinaciclib (SCH 727965) Sigma (SML3722)? Try a better option.
- Dinaciclib (SCH 727965) MedChemExpress (HY-10492)? Try a better option.
- Dinaciclib (SCH 727965) Cayman (14707)? Try a better option.
- Dinaciclib (SCH 727965) APExBIO (A8412)? Try a better option.
- Dinaciclib (SCH 727965) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.