Numerous clinical trials spanning Phase 1 to Phase 3 have evaluated tipifarnib across diverse oncological indications, including HRAS-mutated head and neck squamous cell carcinoma, non-small cell lung cancer, chronic myelomonocytic leukemia, acute myeloid leukemia, and pancreatic adenocarcinoma. Sponsored by biotechnology firms such as Kura Oncology Inc. alongside academic institutions including the National Cancer Institute and Mayo Clinic, these studies reflect varied recruitment statuses ranging from actively recruiting and completed to terminated or withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06540963 | RECRUITING | Neuroblastoma |
Giselle Sholler |
2024-12-06 | PHASE2 |
| NCT05693090 | WITHDRAWN | NSCLC |
Kura Oncology, Inc. |
2023-02-01 | PHASE1 |
| NCT04997902 | COMPLETED | HNSCC |
Kura Oncology, Inc. |
2021-12-07 | PHASE1; PHASE2 |
| NCT03155620 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor |
National Cancer Institute (NCI) |
2017-07-31 | PHASE2 |
| NCT04284774 | ACTIVE_NOT_RECRUITING | Malignant Solid Neoplasm; Recurrent Adrenal Gland Pheochromocytoma; Recurrent Ectomesenchymoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Hepatoblastoma; Recurrent Kidney Wilms Tumor; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Glioma; Recurrent Medulloblastoma; Recurrent Melanoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Rhabdoid Tumor; Recurrent Rhabdoid Tumor of the Kidney; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Recurrent Thyroid Gland Carcinoma; Recurrent WHO Grade 2 Glioma; Refractory Adrenal Gland Pheochromocytoma; Refractory Ependymoma; Refractory Ewing Sarcoma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Glioma; Refractory Medulloblastoma; Refractory Melanoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Rhabdoid Tumor; Refractory Rhabdoid Tumor of the Kidney; Refractory Rhabdomyosarcoma; Refractory Soft Tissue Sarcoma; Refractory Thyroid Gland Carcinoma; Refractory WHO Grade 2 Glioma |
National Cancer Institute (NCI) |
2020-10-13 | PHASE2 |
| NCT03719690 | COMPLETED | HRAS Gene Mutation; HNSCC |
Kura Oncology, Inc. |
2019-03-15 | PHASE2 |
| NCT04865159 | TERMINATED | Advanced Solid Tumor |
Kura Oncology, Inc. |
2021-05-06 | PHASE1 |
| NCT05693090 | Withdrawn | NSCLC |
Kura Oncology Inc. |
2023-02-01 | Phase 1 |
| NCT03496766 | TERMINATED | Non Small Cell Lung Cancer |
Spanish Lung Cancer Group |
2018-05-07 | PHASE2 |
| NCT02535650 | UNKNOWN | Urothelial Carcinoma |
Samsung Medical Center |
2015-11-12 | PHASE2 |
| NCT04997902 | Recruiting | HNSCC |
Kura Oncology Inc. |
2021-12-07 | Phase 1|Phase 2 |
| NCT04865159 | Terminated | Advanced Solid Tumor |
Kura Oncology Inc. |
2021-05-06 | Phase 1 |
| NCT02464228 | COMPLETED | Relapsed or Refractory Peripheral T-Cell Lymphoma |
Kura Oncology, Inc. |
2016-02-25 | PHASE2 |
| NCT02383927 | COMPLETED | Thyroid Cancer; Squamous Cell Carcinoma Head and Neck Cancer (HNSCC); HRAS Mutant Tumor; Other Squamous Cell Carcinoma (SCC) With HRAS Mutant Tumor |
Kura Oncology, Inc. |
2015-05-13 | PHASE2 |
| NCT02807272 | COMPLETED | Leukemia, Myelomonocytic, Chronic |
Kura Oncology, Inc. |
2017-01-10 | PHASE2 |
| NCT00077519 | COMPLETED | Pancreatic Cancer |
Abramson Cancer Center at Penn Medicine |
2004-01 | PHASE1 |
| NCT03719690 | Active not recruiting | HRAS Gene Mutation|HNSCC |
Kura Oncology Inc. |
2018-11-05 | Phase 2 |
| NCT02779777 | TERMINATED | Myelodysplastic Syndromes |
Kura Oncology, Inc. |
2016-06-01 | PHASE2 |
| NCT00244972 | COMPLETED | Advanced Malignant Neoplasm |
National Cancer Institute (NCI) |
2005-10 | PHASE1 |
| NCT02807272 | Completed | Leukemia Myelomonocytic Chronic |
Kura Oncology Inc. |
2016-10 | Phase 2 |
| NCT00093470 | COMPLETED | Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Megakaryoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Myelodysplastic Syndrome With Excess Blasts; Recurrent Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2004-08-18 | PHASE3 |
| NCT01361464 | COMPLETED | Adult Acute Megakaryoblastic Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2011-05 | PHASE2 |
| NCT00470301 | COMPLETED | Breast Cancer; Male Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer |
National Cancer Institute (NCI) |
2007-04 | PHASE1; PHASE2 |
| NCT00454480 | COMPLETED | Leukemia; Myelodysplastic Syndromes |
The University of New South Wales |
2006-08 | PHASE2; PHASE3 |
| NCT00383474 | COMPLETED | Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Megakaryoblastic Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Adult Erythroleukemia; Adult Pure Erythroid Leukemia; Blastic Phase; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Disease; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2006-08 | PHASE1 |
| NCT00602771 | 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) |
2008-01 | PHASE2 |
| NCT00101296 | COMPLETED | Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Erythroid Leukemia (M6); Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5); 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); Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2004-10 | PHASE1 |
| NCT00281957 | COMPLETED | Recurrent Melanoma; Stage IV Melanoma |
National Cancer Institute (NCI) |
2007-08 | PHASE2 |
| NCT00101153 | COMPLETED | Leukemia |
University Health Network, Toronto |
2007-04 | PHASE1 |
| NCT00335764 | COMPLETED | Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor |
National Cancer Institute (NCI) |
2006-04 | PHASE1; PHASE2 |
| NCT00972712 | COMPLETED | Multiple Myeloma |
Emory University |
2006-12 | PHASE1 |
| NCT00079339 | COMPLETED | Untreated Childhood Brain Stem Glioma |
National Cancer Institute (NCI) |
2004-01 | PHASE1; PHASE2 |
| NCT00005845 | COMPLETED | Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Previously Treated Myelodysplastic Syndromes; Refractory Anemia; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Refractory Anemia With Ringed Sideroblasts; Refractory Cytopenia With Multilineage Dysplasia |
National Cancer Institute (NCI) |
2002-06 | PHASE1 |
| NCT00082888 | COMPLETED | Anaplastic Large Cell Lymphoma; Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue; Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Nodal Marginal Zone Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult T-Cell Leukemia/Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Small Lymphocytic Lymphoma; Splenic Marginal Zone Lymphoma |
National Cancer Institute (NCI) |
2004-03-24 | PHASE2 |
| NCT00112853 | 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); Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2005-03 | PHASE1 |
| NCT00847223 | TERMINATED | Mantle Cell Lymphoma |
Lymphoma Study Association |
2007-06 | PHASE2 |
| NCT00021541 | COMPLETED | Neurofibroma, Plexiform; Neurofibromatosis Type I |
National Cancer Institute (NCI) |
2001-07-17 | PHASE2 |
| NCT00025454 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
City of Hope Medical Center |
2001-08 | PHASE1 |
| NCT00082810 | COMPLETED | Estrogen Receptor-positive Breast Cancer; Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer |
National Cancer Institute (NCI) |
2004-03 | PHASE2 |
| NCT00085553 | COMPLETED | Solid Neoplasm |
National Cancer Institute (NCI) |
2004-05-20 | PHASE1 |
| NCT00124644 | TERMINATED | Leukemia |
Ohio State University Comprehensive Cancer Center |
2006-03 | PHASE1 |
| NCT00025038 | COMPLETED | Juvenile Myelomonocytic Leukemia |
National Cancer Institute (NCI) |
2001-06 | PHASE2 |
| NCT00045396 | COMPLETED | Adult Acute Myeloid Leukemia in Remission; 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(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); de Novo Myelodysplastic Syndromes; Secondary Myelodysplastic Syndromes |
National Cancer Institute (NCI) |
2002-06 | PHASE2 |
| NCT00100750 | COMPLETED | Recurrent Breast Carcinoma; Stage IV Breast Cancer |
National Cancer Institute (NCI) |
2005-09 | PHASE1; PHASE2 |
| NCT00005989 | COMPLETED | Lung Cancer |
Mayo Clinic |
2002-11 | PHASE2 |
| NCT00027872 | COMPLETED | Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Adult Acute Basophilic Leukemia; Adult Acute Eosinophilic Leukemia; Adult Acute Erythroid Leukemia (M6); Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monoblastic Leukemia and Acute Monocytic Leukemia (M5); 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); Cellular Diagnosis, Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2001-10 | PHASE2 |
| NCT00049387 | COMPLETED | Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma |
National Cancer Institute (NCI) |
2002-09 | PHASE1 |
| NCT02227901 | COMPLETED | Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma |
National Cancer Institute (NCI) |
2002-09 | PHASE1 |
| NCT00360776 | TERMINATED | Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia; T-cell Large Granular Lymphocyte Leukemia |
National Cancer Institute (NCI) |
2006-06-02 | PHASE2 |
| NCT00005848 | COMPLETED | Prostate Cancer |
Fox Chase Cancer Center |
2000-04 | PHASE2 |
| NCT00047190 | COMPLETED | Essential Thrombocythemia; Polycythemia Vera; Primary Myelofibrosis |
National Cancer Institute (NCI) |
2002-08 | PHASE2 |
| NCT00243035 | TERMINATED | Refractory Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma |
National Cancer Institute (NCI) |
2005-08 | PHASE1; PHASE2 |
| NCT00077363 | COMPLETED | Recurrent Breast Cancer; Stage IV Breast Cancer |
National Cancer Institute (NCI) |
2004-05 | PHASE2 |
| NCT00058097 | COMPLETED | Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma |
National Cancer Institute (NCI) |
2003-08 | PHASE2 |
| NCT00049114 | COMPLETED | Inflammatory Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer |
National Cancer Institute (NCI) |
2003-02 | PHASE2 |
| NCT00096122 | 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); Childhood Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Refractory Anemia With Excess Blasts; Refractory Anemia With Excess Blasts in Transformation; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2004-09 | PHASE1; PHASE2 |
| NCT00070525 | COMPLETED | Childhood High-grade Cerebral Astrocytoma; Childhood Oligodendroglioma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor; Recurrent Childhood Visual Pathway and Hypothalamic Glioma |
National Cancer Institute (NCI) |
2003-11 | PHASE2 |
| NCT00005990 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
NYU Langone Health |
2000-08 | PHASE1 |
| NCT00026104 | COMPLETED | Adenocarcinoma of the Pancreas; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer |
National Cancer Institute (NCI) |
2001-11 | PHASE2 |
| NCT00093418 | 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 in Remission; 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); Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2004-09 | PHASE2 |
| NCT00060125 | COMPLETED | Recurrent Melanoma; Stage IV Melanoma |
National Cancer Institute (NCI) |
2003-05 | PHASE2 |
| NCT00047216 | COMPLETED | Bladder Cancer |
University Health Network, Toronto |
2002-11 | PHASE2 |
| NCT00070252 | COMPLETED | Adult Solid Neoplasm; Inflammatory Breast Carcinoma; Male Breast Carcinoma; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer |
National Cancer Institute (NCI) |
2003-09 | PHASE1; PHASE2 |
| NCT00050141 | COMPLETED | Breast Cancer |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2002-09 | PHASE2 |
| NCT00005859 | COMPLETED | Brain and Central Nervous System Tumors |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2000-05-16 | PHASE1; PHASE2 |
| NCT02210858 | COMPLETED | Accelerated Phase of Disease; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Myelomonocytic Leukemia; Chronic Phase of Disease; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Recurrent Disease |
National Cancer Institute (NCI) |
2000-05 | PHASE1; PHASE2 |
| NCT00005843 | COMPLETED | Pancreatic Cancer |
National Cancer Institute (NCI) |
2000-05 | PHASE2 |
| NCT00005967 | COMPLETED | Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes |
National Cancer Institute (NCI) |
2000-08 | PHASE1 |
| NCT00055757 | COMPLETED | Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer |
National Cancer Institute (NCI) |
2003-10 | PHASE2 |
| NCT00005842 | COMPLETED | Cancer |
National Cancer Institute (NCI) |
2000-06 | PHASE1 |
| NCT00054470 | WITHDRAWN | Breast Cancer |
The University of Texas Health Science Center at San Antonio |
2002-12 | PHASE2 |
| NCT00003707 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
The University of Texas Health Science Center at San Antonio |
1998-10 | PHASE1 |
| NCT00004009 | COMPLETED | Leukemia |
University of Maryland, Baltimore |
1999-06 | PHASE1 |
| NCT00005041 | COMPLETED | Lung Cancer |
NYU Langone Health |
1999-09 | PHASE2 |
| NCT00050154 | COMPLETED | Myelodysplastic Syndrome |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2002-07 | PHASE2 |
| NCT00048503 | COMPLETED | Acute Myeloid Leukemia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2002-06 | PHASE2 |
| NCT00006376 | COMPLETED | Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter |
H. Lee Moffitt Cancer Center and Research Institute |
2000-03 | PHASE2 |
| NCT00025480 | COMPLETED | Lung Cancer |
Abramson Cancer Center at Penn Medicine |
2001-08 | PHASE1 |
| NCT00052728 | COMPLETED | Breast Cancer |
National Cancer Institute (NCI) |
2002-12 | PHASE2 |
| NCT00093990 | COMPLETED | Acute Myeloid Leukemia |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2004-01 | PHASE3 |
| NCT00022451 | COMPLETED | Leukemia |
National Institutes of Health Clinical Center (CC) |
2001-06 | PHASE1 |
| NCT00510939 | UNKNOWN | Acute Myeloid Leukemia |
University of Bologna |
2007-03 | PHASE2 |
| NCT00354146 | COMPLETED | Leukemia, Nonlymphocytic, Acute |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
2001-04 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-09-03)
Check the
Tipifarnib (IND 58359)
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>).
- Tipifarnib (IND 58359) Solubility in DMSO
- Tipifarnib (IND 58359) Stock Solution
- Tipifarnib (IND 58359) Storage
- Tipifarnib (IND 58359) Stability
- Tipifarnib (IND 58359) Molecular Weight
- Tipifarnib (IND 58359) SMILES
- Tipifarnib (IND 58359) CAS Number
- Tipifarnib (IND 58359) Chemical Structure (2D and 3D)
- Tipifarnib (IND 58359) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.