Flavopiridol (Alvocidib) HCl Clinical Trials

Size	Price	Qty
10mg	USD 147
1g	USD 2,990

Clinical Trials

Flavopiridol (Alvocidib) hydrochloride has been evaluated in numerous clinical trials—primarily Phase 1, Phase 2, and combined Phase 1/2 studies—spanning completed, terminated, and withdrawn protocols assessing single-agent or combination regimens. Clinical investigation spans hematologic malignancies, including chronic lymphocytic leukemia, acute myeloid leukemia, multiple myeloma, and lymphomas, as well as solid tumors such as pancreatic adenocarcinoma, hepatoma, and germ cell tumors. Trial sponsors comprise government entities like the National Cancer Institute, academic institutions such as Memorial Sloan Kettering Cancer Center and Mayo Clinic, and pharmaceutical sponsors like Sumitomo Pharma America, Inc.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03593915	TERMINATED	Myelodysplastic Syndromes (MDS)	Sumitomo Pharma America, Inc.	2018-08-29	PHASE1; PHASE2
NCT03969420	TERMINATED	Acute Myeloid Leukemia (AML)	Sumitomo Pharma America, Inc.	2020-01-15	PHASE2
NCT03441555	COMPLETED	Acute Myeloid Leukemia (AML)	AbbVie	2018-05-30	PHASE1
NCT04493099	WITHDRAWN	Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2020-10	PHASE1; PHASE2
NCT03563560	COMPLETED	Acute Myeloid Leukemia	Sumitomo Pharma Co., Ltd.	2018-05-15	PHASE1
NCT03298984	COMPLETED	Acute Myeloid Leukemia	Sumitomo Pharma America, Inc.	2017-09-25	PHASE1
NCT02520011	TERMINATED	Acute Myeloid Leukemia	Sumitomo Pharma America, Inc.	2016-03-14	PHASE2
NCT00634244	COMPLETED	Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2008-10	PHASE2
NCT00957905	COMPLETED	Recurrent Extragonadal Seminoma; Recurrent Malignant Extragonadal Germ Cell Tumor; Recurrent Malignant Extragonadal Non-Seminomatous Germ Cell Tumor; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Ovarian Germ Cell Tumor; Stage III Testicular Cancer; Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor; Stage IV Extragonadal Seminoma; Stage IV Ovarian Germ Cell Tumor	National Cancer Institute (NCI)	2009-06	PHASE2
NCT01349972	COMPLETED	Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2011-04	PHASE2
NCT00094978	TERMINATED	Carcinoma, Small Cell; Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms; Mesothelioma	National Cancer Institute (NCI)	2004-10-25	PHASE1
NCT00735930	COMPLETED	Anemia; Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Thrombocytopenia	National Cancer Institute (NCI)	2008-08	PHASE1
NCT00377104	TERMINATED	B-cell Chronic Lymphocytic Leukemia; Contiguous Stage II Small Lymphocytic Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage I Small Lymphocytic Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Small Lymphocytic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Small Lymphocytic Lymphoma	National Cancer Institute (NCI)	2006-09	PHASE1
NCT00101231	TERMINATED	Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Blastic Phase Chronic Myelogenous Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Relapsing Chronic Myelogenous Leukemia	National Cancer Institute (NCI)	2004-10	PHASE1
NCT00082784	COMPLETED	Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Nodal Marginal Zone Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Refractory Plasma Cell Myeloma; Splenic Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia	National Cancer Institute (NCI)	2004-03	PHASE1
NCT00112684	TERMINATED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2006-02	PHASE1
NCT00445341	COMPLETED	Lymphoma	National Cancer Institute (NCI)	2006-11-27	PHASE1; PHASE2
NCT00991952	COMPLETED	Adenocarcinoma of the Gastroesophageal Junction; Diffuse Adenocarcinoma of the Stomach; Intestinal Adenocarcinoma of the Stomach; Mixed Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage IIIA Gastric Cancer; Stage IIIB Gastric Cancer; Stage IIIC Gastric Cancer; Stage IV Gastric Cancer	National Cancer Institute (NCI)	2009-09	PHASE2
NCT00464633	COMPLETED	Leukemia, Lymphocytic, Chronic	Sanofi	2007-03	PHASE2
NCT00098579	COMPLETED	Gastrointestinal Stromal Tumor; Recurrent Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma	National Cancer Institute (NCI)	2004-10	PHASE1
NCT00112723	TERMINATED	Adult Lymphocyte Depletion Hodgkin Lymphoma; Adult Lymphocyte Predominant Hodgkin Lymphoma; Adult Mixed Cellularity Hodgkin Lymphoma; Adult Nodular Sclerosis Hodgkin Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Refractory Multiple Myeloma; Splenic Marginal Zone Lymphoma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma; Waldenström Macroglobulinemia	National Cancer Institute (NCI)	2005-12	PHASE1; PHASE2
NCT00470197	COMPLETED	Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Malignant Neoplasm; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2007-04	PHASE1
NCT00795002	COMPLETED	Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2008-11	PHASE2
NCT00007917	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2001-01	PHASE1
NCT01076556	TERMINATED	Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage I Small Lymphocytic Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage II Small Lymphocytic Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Small Lymphocytic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Small Lymphocytic Lymphoma	National Cancer Institute (NCI)	2010-04	PHASE1
NCT00083122	COMPLETED	Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Primary Peritoneal Cavity Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Primary Peritoneal Cavity Cancer	National Cancer Institute (NCI)	2004-04	PHASE2
NCT00046917	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2002-07	PHASE1
NCT00278330	COMPLETED	Blastic Phase Chronic Myelogenous Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Refractory Anemia With Excess Blasts; Relapsing Chronic Myelogenous Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2006-01	PHASE1
NCT00098371	TERMINATED	B-cell Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia	National Cancer Institute (NCI)	2005-04	PHASE2
NCT00080990	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2004-02	PHASE1
NCT00324480	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2006-03	PHASE1
NCT00072436	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2003-09	PHASE1
NCT00058240	COMPLETED	B-cell Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Waldenström Macroglobulinemia	National Cancer Institute (NCI)	2003-04	PHASE1; PHASE2
NCT00058227	COMPLETED	B-cell Chronic Lymphocytic Leukemia; Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Contiguous Stage II Small Lymphocytic Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Progressive Hairy Cell Leukemia, Initial Treatment; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Splenic Marginal Zone Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Mantle Cell Lymphoma; Stage I Marginal Zone Lymphoma; Stage I Small Lymphocytic Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Small Lymphocytic Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Small Lymphocytic Lymphoma; Untreated Hairy Cell Leukemia; Waldenström Macroglobulinemia	National Cancer Institute (NCI)	2003-04	PHASE1
NCT00042874	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2002-05	PHASE1
NCT00047307	COMPLETED	Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer	National Cancer Institute (NCI)	2002-08	PHASE1
NCT00407966	COMPLETED	Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2006-10	PHASE2
NCT00331682	COMPLETED	Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer	National Cancer Institute (NCI)	2006-03	PHASE2
NCT00079352	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2004-04	PHASE1
NCT00016016	COMPLETED	Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia	National Cancer Institute (NCI)	2001-02	PHASE1; PHASE2
NCT00047203	COMPLETED	Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma	National Cancer Institute (NCI)	2002-09	PHASE2
NCT00003620	COMPLETED	B-cell Chronic Lymphocytic Leukemia; Refractory Chronic Lymphocytic Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia	National Cancer Institute (NCI)	1999-06	PHASE2
NCT00070239	TERMINATED	Hematopoietic/Lymphoid Cancer; Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2003-08	PHASE1
NCT00021073	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2001-05	PHASE1
NCT00045448	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Memorial Sloan Kettering Cancer Center	2002-04	PHASE1
NCT00112723	Terminated	Adult Lymphocyte Depletion Hodgkin Lymphoma\|Adult Lymphocyte Predominant Hodgkin Lymphoma\|Adult Mixed Cellularity Hodgkin Lymphoma\|Adult Nodular Sclerosis Hodgkin Lymphoma\|Anaplastic Large Cell Lymphoma\|Angioimmunoblastic T-cell Lymphoma\|Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue\|Nodal Marginal Zone B-cell Lymphoma\|Recurrent Adult Diffuse Large Cell Lymphoma\|Recurrent Adult Diffuse Mixed Cell Lymphoma\|Recurrent Adult Diffuse Small Cleaved Cell Lymphoma\|Recurrent Adult Grade III Lymphomatoid Granulomatosis\|Recurrent Adult Hodgkin Lymphoma\|Recurrent Adult T-cell Leukemia/Lymphoma\|Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma\|Recurrent Grade 1 Follicular Lymphoma\|Recurrent Grade 2 Follicular Lymphoma\|Recurrent Grade 3 Follicular Lymphoma\|Recurrent Mantle Cell Lymphoma\|Recurrent Marginal Zone Lymphoma\|Recurrent Mycosis Fungoides/Sezary Syndrome\|Recurrent Small Lymphocytic Lymphoma\|Refractory Multiple Myeloma\|Splenic Marginal Zone Lymphoma\|Stage I Multiple Myeloma\|Stage II Multiple Myeloma\|Stage III Multiple Myeloma\|Waldenström Macroglobulinemia	National Cancer Institute (NCI)	2005-12	Phase 1\|Phase 2
NCT00098371	Terminated	B-cell Chronic Lymphocytic Leukemia\|Prolymphocytic Leukemia\|Refractory Chronic Lymphocytic Leukemia	National Cancer Institute (NCI)	2005-04	Phase 2
NCT00012181	COMPLETED	Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Liver Cancer; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Malignant Germ Cell Tumor; Recurrent Childhood Medulloblastoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor; Recurrent Childhood Visual Pathway and Hypothalamic Glioma; Recurrent Childhood Visual Pathway Glioma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Neuroblastoma; Recurrent Osteosarcoma; Recurrent Retinoblastoma; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Recurrent/Refractory Childhood Hodgkin Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	2001-04	PHASE1
NCT00039455	TERMINATED	HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer	National Cancer Institute (NCI)	2002-04	PHASE1
NCT00101231	Terminated	Adult Acute Basophilic Leukemia\|Adult Acute Eosinophilic Leukemia\|Adult Acute Megakaryoblastic Leukemia (M7)\|Adult Acute Minimally Differentiated Myeloid Leukemia (M0)\|Adult Acute Monoblastic Leukemia (M5a)\|Adult Acute Monocytic Leukemia (M5b)\|Adult Acute Myeloblastic Leukemia With Maturation (M2)\|Adult Acute Myeloblastic Leukemia Without Maturation (M1)\|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities\|Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)\|Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)\|Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)\|Adult Acute Myelomonocytic Leukemia (M4)\|Adult Erythroleukemia (M6a)\|Adult Pure Erythroid Leukemia (M6b)\|Blastic Phase Chronic Myelogenous Leukemia\|Recurrent Adult Acute Lymphoblastic Leukemia\|Recurrent Adult Acute Myeloid Leukemia\|Relapsing Chronic Myelogenous Leukemia	National Cancer Institute (NCI)	2004-10	Phase 1
NCT00006485	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Memorial Sloan Kettering Cancer Center	2000-09	PHASE1
NCT00003690	COMPLETED	Breast Cancer; Melanoma (Skin); Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Mayo Clinic	1998-12	PHASE1
NCT00058240	Completed	B-cell Chronic Lymphocytic Leukemia\|Recurrent Small Lymphocytic Lymphoma\|Refractory Chronic Lymphocytic Leukemia\|Waldenström Macroglobulinemia	National Cancer Institute (NCI)	2003-04	Phase 1\|Phase 2
NCT00016185	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Barbara Ann Karmanos Cancer Institute	2001-03	PHASE1
NCT00005974	COMPLETED	Sarcoma	NCIC Clinical Trials Group	2000-07-04	PHASE2
NCT00003256	COMPLETED	Prostate Cancer	National Cancer Institute (NCI)	1998-05	PHASE2
NCT00005074	COMPLETED	Lymphoma	NCIC Clinical Trials Group	2000-01-24	PHASE2
NCT00003004	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific	Memorial Sloan Kettering Cancer Center	1997-07	PHASE1
NCT00005971	COMPLETED	Melanoma (Skin)	NCIC Clinical Trials Group	2000-07-04	PHASE2
NCT00003039	COMPLETED	Lymphoma	National Cancer Institute (NCI)	1997-09	PHASE2
NCT00087282	COMPLETED	Liver Cancer	Memorial Sloan Kettering Cancer Center	2004-06	PHASE2
NCT00006245	COMPLETED	Esophageal Cancer	Memorial Sloan Kettering Cancer Center	2000-07	PHASE2
NCT00064285	COMPLETED	Leukemia	Virginia Commonwealth University	2003-06	PHASE1
NCT00020189	COMPLETED	Head and Neck Cancer; Thromboembolism	National Cancer Institute (NCI)	2000-06	PHASE2
NCT00019344	COMPLETED	Lymphoma; Prostate Cancer; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific	National Cancer Institute (NCI)	1997-08	PHASE1
NCT00020332	COMPLETED	Breast Cancer	National Cancer Institute (NCI)	2000-10	PHASE1; PHASE2
NCT00023894	COMPLETED	Endometrial Cancer	Gynecologic Oncology Group	2001-07	PHASE2
NCT00016939	COMPLETED	Kidney Cancer	SWOG Cancer Research Network	2001-05	PHASE2

(data from https://clinicaltrials.gov, updated on 2023-11-09)

Check the Flavopiridol (Alvocidib) HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Flavopiridol hydrochloride competitively binds the ATP-binding site of cyclin-dependent kinases (CDK1, CDK2, CDK4, and CDK6), thereby suppressing kinase activity and downregulating cyclin D1 expression. This targeted molecular inhibition induces G1 and G2 phase cell-cycle arrest and activates caspase-3/7-mediated apoptosis, ultimately inhibiting tumor cell proliferation in clinical trial indications such as chronic lymphocytic leukemia and acute myeloid leukemia.

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>).