Numerous clinical trials spanning Early Phase 1 to Phase 3 have evaluated Triapine (3-AP) in diverse cancers, including advanced adult solid tumors, hematologic malignancies such as non-Hodgkin lymphoma and chronic myelogenous leukemia, and pancreatic, non-small cell lung, and prostate cancers. Spearheaded by government entities like the National Cancer Institute, industry partners, and academic institutions, trial statuses encompass active, recruiting, completed, and terminated. Investigations include combination regimens with gemcitabine and therapeutic evaluations in advanced prostate carcinoma.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06410248 | RECRUITING | Recurrent Glioblastoma, IDH-Wildtype; Recurrent WHO Grade 2 Glioma; Recurrent WHO Grade 3 Glioma; Recurrent WHO Grade 4 Glioma |
Northwestern University |
2024-07-23 | PHASE1 |
| NCT06860594 | RECRUITING | Astrocytoma, IDH-Mutant, Grade 2; Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant; Recurrent Adult Diffuse Midline Glioma, H3 K27-Mutant; Recurrent Astrocytoma, IDH-Mutant; Recurrent Astrocytoma, IDH-Mutant, Grade 3; Recurrent Astrocytoma, IDH-Mutant, Grade 4; Recurrent Glioblastoma, IDH-Wildtype |
National Cancer Institute (NCI) |
2025-07-30 | PHASE1 |
| NCT05724108 | ACTIVE_NOT_RECRUITING | Metastatic Neuroendocrine Tumor |
National Cancer Institute (NCI) |
2023-08-30 | PHASE2 |
| NCT04494113 | ACTIVE_NOT_RECRUITING | Endometrial Serous Adenocarcinoma |
National Cancer Institute (NCI) |
2022-02-08 | EARLY_PHASE1 |
| NCT04234568 | ACTIVE_NOT_RECRUITING | Metastatic Digestive System Neuroendocrine Neoplasm; Metastatic Neuroendocrine Tumor |
National Cancer Institute (NCI) |
2020-07-20 | PHASE1 |
| NCT02595879 | ACTIVE_NOT_RECRUITING | Advanced Cervical Adenocarcinoma; Advanced Cervical Adenosquamous Carcinoma; Advanced Cervical Squamous Cell Carcinoma; Advanced Vaginal Adenocarcinoma; Advanced Vaginal Adenosquamous Carcinoma; Advanced Vaginal Squamous Cell Carcinoma; Stage IB2 Cervical Cancer AJCC v6 and v7; Stage II Cervical Cancer AJCC v7; Stage II Vaginal Cancer AJCC v6 and v7; Stage III Vaginal Cancer AJCC v6 and v7; Stage IIIB Cervical Cancer AJCC v6 and v7; Stage IVA Cervical Cancer AJCC v6 and v7; Stage IVA Vaginal Cancer AJCC v6 and v7 |
National Cancer Institute (NCI) |
2019-09-18 | PHASE1 |
| NCT02466971 | ACTIVE_NOT_RECRUITING | Advanced Vaginal Adenocarcinoma; Advanced Vaginal Adenosquamous Carcinoma; Advanced Vaginal Squamous Cell Carcinoma; Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Stage IB2 Cervical Cancer AJCC v6 and v7; Stage II Cervical Cancer AJCC v7; Stage II Vaginal Cancer AJCC v6 and v7; Stage IIA Cervical Cancer AJCC v7; Stage IIB Cervical Cancer AJCC v6 and v7; Stage III Vaginal Cancer AJCC v6 and v7; Stage IIIB Cervical Cancer AJCC v6 and v7; Stage IV Vaginal Cancer AJCC v6 and v7; Stage IVA Cervical Cancer AJCC v6 and v7; Stage IVA Vaginal Cancer AJCC v6 and v7; Unresectable Vaginal Carcinoma; Vaginal Adenocarcinoma; Vaginal Adenosquamous Carcinoma; Vaginal Carcinoma; Vaginal Squamous Cell Carcinoma, Not Otherwise Specified |
National Cancer Institute (NCI) |
2016-05-10 | PHASE3 |
| NCT00288093 | COMPLETED | Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer AJCC v6 and v7 |
National Cancer Institute (NCI) |
2006-12-20 | PHASE1 |
| NCT00293345 | COMPLETED | Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Primary Central Nervous System Hodgkin Lymphoma; Primary Central Nervous System Non-Hodgkin Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic 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; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-cell Leukemia/Lymphoma; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia |
National Cancer Institute (NCI) |
2006-06 | PHASE1 |
| NCT00941070 | COMPLETED | Recurrent Cervical Cancer; Recurrent Vaginal Cancer; Stage IB Cervical Cancer; Stage II Vaginal Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage III Vaginal Cancer; Stage IVA Cervical Cancer; Stage IVA Vaginal Cancer; Stage IVB Cervical Cancer; Stage IVB Vaginal Cancer; Therapy-related Toxicity |
National Cancer Institute (NCI) |
2009-07 | PHASE2 |
| NCT00381550 | COMPLETED | Accelerated Phase Chronic Myelogenous Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blastic Phase Chronic Myelogenous Leukemia; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Essential Thrombocythemia; Philadelphia Chromosome Negative Chronic Myelogenous Leukemia; Polycythemia Vera; Primary Myelofibrosis; Relapsing Chronic Myelogenous Leukemia |
National Cancer Institute (NCI) |
2006-08 | PHASE2 |
| NCT00390052 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2006-12 | PHASE1 |
| NCT00075504 | COMPLETED | Stage II Gallbladder Cancer; Stage IIIA Gallbladder Cancer; Stage IIIB Gallbladder Cancer; Stage IVA Gallbladder Cancer; Stage IVB Gallbladder Cancer |
National Cancer Institute (NCI) |
2003-11 | PHASE2 |
| NCT00335998 | COMPLETED | Recurrent Cervical Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Vaginal Cancer; Recurrent Vulvar Cancer; Stage III Vaginal Cancer; Stage IIIA Cervical Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Vulvar Cancer; Stage IIIB Cervical Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Vulvar Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Vulvar Cancer; Stage IV Ovarian Epithelial Cancer; Stage IVA Cervical Cancer; Stage IVA Vaginal Cancer; Stage IVB Cervical Cancer; Stage IVB Vaginal Cancer |
National Cancer Institute (NCI) |
2006-03 | PHASE1 |
| NCT00084877 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2004-03 | PHASE1 |
| NCT00077181 | COMPLETED | Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; 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); Blastic Phase Chronic Myelogenous Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2004-01 | PHASE1 |
| NCT00079014 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2004-01 | PHASE1 |
| NCT00077415 | COMPLETED | Lung Cancer |
Cancer Therapeutics Research Group |
2004-04 | PHASE2 |
| NCT00077545 | COMPLETED | Adenocarcinoma of the Esophagus; Recurrent Esophageal Cancer; Stage IV Esophageal Cancer |
National Cancer Institute (NCI) |
2004-01 | PHASE2 |
| NCT00081276 | COMPLETED | Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer |
National Cancer Institute (NCI) |
2005-07 | PHASE2 |
| NCT00064051 | COMPLETED | Pancreatic Cancer |
Vion Pharmaceuticals |
2003-01 | PHASE2 |
| NCT00085371 | COMPLETED | Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer |
National Cancer Institute (NCI) |
2004-07 | PHASE2 |
| NCT00293345 | Completed | Anaplastic Large Cell Lymphoma|Angioimmunoblastic T-cell Lymphoma|Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue|Intraocular Lymphoma|Nodal Marginal Zone B-cell Lymphoma|Primary Central Nervous System Hodgkin Lymphoma|Primary Central Nervous System Non-Hodgkin Lymphoma|Recurrent Adult Burkitt Lymphoma|Recurrent Adult Diffuse Large Cell Lymphoma|Recurrent Adult Diffuse Mixed Cell Lymphoma|Recurrent Adult Diffuse Small Cleaved Cell Lymphoma|Recurrent Adult Hodgkin Lymphoma|Recurrent Adult Immunoblastic Large Cell Lymphoma|Recurrent Adult Lymphoblastic 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|Small Intestine Lymphoma|Splenic Marginal Zone Lymphoma|Stage III Adult Burkitt Lymphoma|Stage III Adult Diffuse Large Cell Lymphoma|Stage III Adult Diffuse Mixed Cell Lymphoma|Stage III Adult Diffuse Small Cleaved Cell Lymphoma|Stage III Adult Hodgkin Lymphoma|Stage III Adult Immunoblastic Large Cell Lymphoma|Stage III Adult Lymphoblastic Lymphoma|Stage III Adult T-cell Leukemia/Lymphoma|Stage III Cutaneous T-cell Non-Hodgkin Lymphoma|Stage III Grade 1 Follicular Lymphoma|Stage III Grade 2 Follicular Lymphoma|Stage III Grade 3 Follicular Lymphoma|Stage III Mantle Cell Lymphoma|Stage III Marginal Zone Lymphoma|Stage III Mycosis Fungoides/Sezary Syndrome|Stage III Small Lymphocytic Lymphoma|Stage IV Adult Burkitt Lymphoma|Stage IV Adult Diffuse Large Cell Lymphoma|Stage IV Adult Diffuse Mixed Cell Lymphoma|Stage IV Adult Diffuse Small Cleaved Cell Lymphoma|Stage IV Adult Hodgkin Lymphoma|Stage IV Adult Immunoblastic Large Cell Lymphoma|Stage IV Adult Lymphoblastic Lymphoma|Stage IV Adult T-cell Leukemia/Lymphoma|Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma|Stage IV Grade 1 Follicular Lymphoma|Stage IV Grade 2 Follicular Lymphoma|Stage IV Grade 3 Follicular Lymphoma|Stage IV Mantle Cell Lymphoma|Stage IV Marginal Zone Lymphoma|Stage IV Mycosis Fungoides/Sezary Syndrome|Stage IV Small Lymphocytic Lymphoma|Unspecified Adult Solid Tumor Protocol Specific|Waldenström Macroglobulinemia |
National Cancer Institute (NCI) |
2006-06 | Phase 1 |
| NCT00095888 | TERMINATED | Male Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer |
National Cancer Institute (NCI) |
2004-10 | PHASE2 |
| NCT00078975 | COMPLETED | Pancreatic Cancer |
University Health Network, Toronto |
2004-04 | PHASE2 |
| NCT00075660 | COMPLETED | Kidney Cancer |
NCIC Clinical Trials Group |
2004-05-11 | PHASE2 |
| NCT00077350 | COMPLETED | Recurrent Non-small Cell Lung Cancer |
National Cancer Institute (NCI) |
2004-07 | PHASE2 |
| NCT00064090 | COMPLETED | Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms |
Vion Pharmaceuticals |
2003-03 | PHASE1 |
| NCT00004213 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Vion Pharmaceuticals |
1998-05 | PHASE1 |
| NCT00054015 | COMPLETED | Prostate Cancer |
Vion Pharmaceuticals |
2002-12 | PHASE2 |
| NCT00006218 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Vion Pharmaceuticals |
2000-05 | PHASE1 |
| NCT00077558 | COMPLETED | Leukemia; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Diseases |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2004-01 | PHASE1 |
| NCT00016874 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Vion Pharmaceuticals |
2000-12 | PHASE1 |
| NCT00064064 | COMPLETED | Lung Cancer |
Vion Pharmaceuticals |
2003-01 | PHASE2 |
| NCT00024323 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Vion Pharmaceuticals |
2001-03 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-01)
Check the
Triapine (3-AP)
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>).
Note: Technical data last updated: Sep 1, 2026.