Clinical Trials

Camptothecin and its derivatives have been evaluated across numerous clinical trials—spanning Early Phase 1 through Phase 4—for indications including solid tumors, small cell lung, gastric, pancreatic, colorectal, urological, and central nervous system cancers such as glioblastoma multiforme. Sponsored by academic centers, government organizations like the National Cancer Institute, and industry partners, these studies investigate diverse formulation and combination strategies. Encompassing active, recruiting, completed, terminated, and withdrawn statuses, this research reflects both historical progress and ongoing therapeutic development.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07714083 NOT_YET_RECRUITING
Post Traumatic Stress Disorder
Boston University
 2026-10
NCT06986811 RECRUITING
Locally Resectable Paediatric Tumours
CEBIOTEX
 2025-05-06 PHASE2
NCT07490717 ENROLLING_BY_INVITATION
Post-traumatic Stress Disorder (PTSD); Post-traumatic Stress Symptoms; Opioid Use Disorder (OUD); Stimulant Use Disorder; Stimulant Use & Co-occuring Opioid Use Disorders; Co-occurring Mental and Substance Use Disorders; Medications for Opioid Use Disorder
University of Arkansas
 2026-01-20
NCT06923423 RECRUITING
PTSD - Post Traumatic Stress Disorder; PTSD and Alcohol Use Disorder; PTSD and Trauma-related Symptoms; Substance Use Disorder (SUD); Depression; Mental Health; Trauma; Trauma Exposure; Traumatic Stress Disorder; Traumatic Stress; Post Traumatic Stress Symptoms
University of Arkansas
 2025-07-07
NCT06088303 RECRUITING
Stress Disorders, Post-Traumatic
Boston University
 2025-01-15
NCT06957067 RECRUITING
Post Traumatic Stress Disorder
United States Department of Defense
 2025-03-17
NCT07176273 RECRUITING
Posttraumatic Stress Disorder; PTSD
The University of Texas Health Science Center at San Antonio
 2025-12-12
NCT06925867 RECRUITING
PTSD - Post Traumatic Stress Disorder
Ohio State University
 2025-01-10
NCT07195799 RECRUITING
Non-Hodgkin Lymphoma
The First Affiliated Hospital with Nanjing Medical University
 2024-12-31 PHASE2
NCT05795179 RECRUITING
Self-Control
NYU Langone Health
 2024-10-01
NCT07238192 RECRUITING
Posttraumatic Stress Disorder (PTSD); Suicidal Ideation; Suicide Attempt
Ohio State University
 2026-01-28
NCT07337226 RECRUITING
Idiopathic Parkinson's Disease (PD)
Fondazione Policlinico Universitario Campus Bio-Medico
 2026-02-14
NCT07105345 RECRUITING
Posttraumatic Stress Disorder
Far Eastern Memorial Hospital
 2025-09-01
NCT06995612 ENROLLING_BY_INVITATION
PTSD; Concussion, Mild
San Diego Veterans Healthcare System
 2024-12-01
NCT05837845 RECRUITING
PTSD
Patricia Suppes
 2025-02-10 PHASE2
NCT07060144 RECRUITING
Posttraumatic Stress Disorder (PTSD); Pregnancy
University of Texas at Austin
 2025-08-01
NCT02560805 RECRUITING
Stress Disorders, Post-Traumatic
Emory University
 2015-10 PHASE2
NCT05310097 RECRUITING
PTSD
Boston University
 2023-01-04
NCT06000475 RECRUITING
Stress Disorders, Post-Traumatic
VA Office of Research and Development
 2024-10-15
NCT04425395 RECRUITING
Healthy
Centre Hospitalier Universitaire de Saint Etienne
 2022-05-11
NCT04423874 RECRUITING
Healthy
Centre Hospitalier Universitaire de Saint Etienne
 2022-05-25
NCT06649084 ENROLLING_BY_INVITATION
Primary Progressive Aphasia; Semantic Dementia; Semantic Memory Disorder; Logopenic Progressive Aphasia; Nonfluent Aphasia, Progressive; Aphasia; Aphasia, Progressive
University of Texas at Austin
 2023-05-02
NCT03978442 COMPLETED
Smoking; Stress Disorders, Post-Traumatic
VA Office of Research and Development
 2019-11-07 PHASE4
NCT05037175 ACTIVE_NOT_RECRUITING
Posttraumatic Stress Disorder
Stanford University
 2022-03-22
NCT06950723 NOT_YET_RECRUITING
Hypoxic Ischemic Encephalopathy of Newborn
Cairo University
 2025-05-10
NCT06601322 COMPLETED
Left Branch Bundle Block; RV - Right Ventricular Abnormality
Virginia Commonwealth University
 2024-08-23
NCT05107752 COMPLETED
PTSD; Trauma and Stressor Related Disorders; Trauma, Psychological; Post Traumatic Stress Disorder
Ohio State University
 2022-01-03 PHASE2
NCT07137676 COMPLETED
Geriatric Patients in a Pre-rehabilitative Treatment; Mild Cognitive Impairment (MCI)
St. Franziskus Hospital
 2023-12-16
NCT06657365 COMPLETED
Facial Wrinkles; Anti-Aging; Wrinkles and Rhytides; Wrinkles Such as Nasolabial Folds; Wrinkles
CLASSYS Inc.
 2024-09-29
NCT05326100 UNKNOWN
MTBI - Mild Traumatic Brain Injury; Dysfunction of Vestibular System
Naval Health Research Center
 2023-10-01
NCT05067244 COMPLETED
Post Traumatic Stress Disorder
Remedy
 2021-10-04 PHASE2
NCT04516434 COMPLETED
Urinary Bladder, Underactive
Duke University
 2021-09-01
NCT05275842 COMPLETED
PTSD; Hiv
Medical University of South Carolina
 2022-07-13
NCT05846815 COMPLETED
Attention Deficit Disorder With Hyperactivity
Peili Vision Ltd.
 2023-11-06
NCT04690582 COMPLETED
Suicidal Ideation; Suicide, Attempted; Ptsd
Ohio State University
 2021-01-15
NCT05891028 UNKNOWN
Colorectal Cancer
Peking Union Medical College Hospital
 2023-05-07 EARLY_PHASE1
NCT05460299 UNKNOWN
Multiple Sclerosis
Anas Radi Hassan Alashram
 2023-07-04
NCT05424146 COMPLETED
Post Traumatic Stress Disorder
Rush University Medical Center
 2022-06-06
NCT02769962 TERMINATED
Urothelial Carcinoma; Urothelial Cancer; Lung Neoplasms; Small Cell Lung Cancer; Prostate Cancer
National Cancer Institute (NCI)
 2016-05-09 PHASE1; PHASE2
NCT03605342 TERMINATED
Post-Traumatic Stress Disorders; Opiate Use Disorder
VA Office of Research and Development
 2018-10-01 PHASE2
NCT05981287 COMPLETED
Cerebral Palsy
Riphah International University
 2022-09-15
NCT05674591 COMPLETED
Depression; Anxiety; PTSD
British University In Egypt
 2021-01-05
NCT06483633 COMPLETED
Sleep Quality; Vascular Function
Beijing Sport University
 2022-08-01
NCT04321655 UNKNOWN
Knee Osteoarthritis
Asir John Samuel
 2022-04-01
NCT03260127 COMPLETED
Posttraumatic Stress Disorder
VA Office of Research and Development
 2018-07-02
NCT04611048 SUSPENDED
Small Fiber Neuropathy
Université Catholique de Louvain
 2020-10-10
NCT04956718 COMPLETED
Analgesia
University Children's Hospital Basel
 2021-10-21
NCT03492021 COMPLETED
Rehabilitative Nutrition for Muscle Recovery From ACL Reconstruction
University of Connecticut
 2018-02-01
NCT03939247 TERMINATED
Tendinopathy
University of Liege
 2019-04-25
NCT05120674 TERMINATED
PTSD
VA Eastern Kansas
 2018-08-07
NCT03384706 COMPLETED
Posttraumatic Stress Disorder
University of Cincinnati
 2017-09-06
NCT03033602 COMPLETED
PTSD
Boston VA Research Institute, Inc.
 2015-07-20
NCT05031728 COMPLETED
Posttraumatic Stress Disorder (PTSD)
British University In Egypt
 2017-01-01
NCT02925975 UNKNOWN
Portal Hypertension; Cirrhosis
Changqing Yang
 2015-01 PHASE4
NCT03702166 COMPLETED
Stress Disorders, Post-Traumatic; Tinnitus
The University of Texas Health Science Center at San Antonio
 2019-01-04
NCT02366403 COMPLETED
Stress Disorders, Post-Traumatic
VA Office of Research and Development
 2015-10-14
NCT00576654 COMPLETED
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Triple-Negative Breast Carcinoma; Unresectable Solid Neoplasm
National Cancer Institute (NCI)
 2008-03-18 PHASE1
NCT03894800 COMPLETED
Acute Pain; Trauma; Hypovolemia
Oslo University Hospital
 2019-04-23 PHASE4
NCT02575638 UNKNOWN
Malignant Lymphoma of Extranodal and/or Solid Organ Site; Solid Tumor
Cao Pharmaceuticals Inc.
 2008-07 PHASE1
NCT02773693 UNKNOWN
Trauma; Insomnia; Nightmares
University of North Texas, Denton, TX
 2016-08
NCT02879526 UNKNOWN
Relapse/Refratory Peripheral T Cell Lymphoma
The First Affiliated Hospital with Nanjing Medical University
 2016-08 PHASE2
NCT03069950 WITHDRAWN
Colorectal Adenocarcinoma Metastatic to the Liver
Memorial Sloan Kettering Cancer Center
 2017-02-28 PHASE2
NCT02290847 COMPLETED
Posttraumatic Stress Disorder; PTSD
The University of Texas Health Science Center at San Antonio
 2014-09-19
NCT01928732 COMPLETED
Post-Traumatic Stress Disorder
VA Office of Research and Development
 2014-10-31
NCT01847469 COMPLETED
Alcohol Dependence; Post-Traumatic Stress Disorder (PTSD)
Yale University
 2013-06 PHASE2
NCT01628718 COMPLETED
Posttraumatic Stress Disorder
Veterans Medical Research Foundation
 2013-03
NCT02574429 COMPLETED
Borderline Personality Disorder; Posttraumatic Stress Disorder
St. Joseph's Healthcare Hamilton
 2016-04
NCT01663337 UNKNOWN
PTSD; Alcohol Abuse; Alcohol Dependence
University of Washington
 2013-03
NCT01943162 COMPLETED
PTSD With a History of Mild to Moderate TBI
San Diego Veterans Healthcare System
 2012-08
NCT01901848 COMPLETED
Stress Disorders, Post-Traumatic; Smoking
VA Office of Research and Development
 2013-12-11 PHASE2; PHASE3
NCT01971541 WITHDRAWN
Posttraumatic Stress Disorder; Depression
US Department of Veterans Affairs
 2014-04 PHASE2; PHASE3
NCT02610049 TERMINATED
Post-traumatic Stress Disorder; Stress Disorder, Post-Traumatic
Hampton VA Medical Center
 2013-11
NCT02437240 UNKNOWN
Other Functional Disturbances Following Cardiac Surgery
National Yang Ming Chiao Tung University
 2014-08
NCT01803269 TERMINATED
Extensive Stage Small Cell Lung Cancer; Recurrent Small Cell Lung Cancer
University of Chicago
 2013-01-16 PHASE2
NCT02485080 WITHDRAWN
PT-NANBH
Stanford University
 2015-09 PHASE4
NCT00607815 COMPLETED
PTSD
VA Office of Research and Development
 2009-06-15
NCT00639288 COMPLETED
Alcohol Dependence; PTSD
Yale University
 2008-03 PHASE2; PHASE3
NCT00958217 COMPLETED
Depressive Symptoms; Substance-related Disorders; Posttraumatic Stress Disorders
VA Office of Research and Development
 2009-12
NCT01870271 COMPLETED
PTSD
Goethe University
 2012-11
NCT01783496 COMPLETED
Skin Aging
Valeant Pharmaceuticals
 2013-01
NCT00941629 COMPLETED
Post-Traumatic Stress Disorder
University of Wisconsin, Madison
 2009-12 PHASE3
NCT01014767 TERMINATED
Brain Cancer; Choroid Plexus Tumors
Tufts Medical Center
 2009-11 PHASE3
NCT00045201 ACTIVE_NOT_RECRUITING
Adult Solid Neoplasm
National Cancer Institute (NCI)
 2002-06-13 PHASE1
NCT01244477 COMPLETED
Stress Disorders, Post Traumatic; Trust
VA Office of Research and Development
 2011-05-16
NCT02690740 COMPLETED
Allergic Rhinitis
Zentrums für Rhinologie und Allergologie Wiesbaden
 2012-12
NCT00725192 UNKNOWN
Posttraumatic Stress Disorder
Center for Trauma Recovery, St Louis
 2008-07
NCT00333502 COMPLETED
Cancer; Solid Tumor
NewLink Genetics Corporation
 2006-05 PHASE1; PHASE2
NCT00983788 COMPLETED
Carnitine Palmitoyltransferase II Deficiency; Very Long Chain Acyl Coa Dehydrogenase Deficiency
Rigshospitalet, Denmark
 2009-10 PHASE2
NCT01748019 COMPLETED
Solid Tumors
sigma-tau i.f.r. S.p.A.
 2007-06 PHASE1
NCT00617786 COMPLETED
Incontinence
Corewell Health East
 2008-10
NCT00546910 COMPLETED
Attention Deficit Hyperactivity Disorder
Eli Lilly and Company
 2007-10 PHASE4
NCT00612638 COMPLETED
Glioblastoma; Gliosarcoma
Duke University
 2005-01 PHASE1
NCT00249990 COMPLETED
Corpus Uteri; Endometrial Cancer
University of New Mexico
 2003-04 PHASE2
NCT00006267 WITHDRAWN
Ovarian Cancer; Primary Peritoneal Cavity Cancer
Gynecologic Oncology Group
 PHASE2
NCT00066391 COMPLETED
Penile Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 2003-06 PHASE2
NCT00006082 COMPLETED
Lung Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 2000-05 PHASE2
NCT00003548 COMPLETED
Cancer
NYU Langone Health
 1998-08 PHASE1
NCT00006026 COMPLETED
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 2000-05 PHASE2
NCT00002671 COMPLETED
Ovarian Cancer
NYU Langone Health
 1995-12 PHASE2
NCT00005826 COMPLETED
Brain and Central Nervous System Tumors
European Organisation for Research and Treatment of Cancer - EORTC
 2000-03 PHASE2
NCT00005877 UNKNOWN
Colorectal Cancer
Astex Pharmaceuticals, Inc.
 1999-09 PHASE2
NCT00005870 UNKNOWN
Pancreatic Cancer
Astex Pharmaceuticals, Inc.
 1999-03 PHASE3
NCT00005869 UNKNOWN
Pancreatic Cancer
Astex Pharmaceuticals, Inc.
 1998-11 PHASE3
NCT00005873 COMPLETED
Breast Cancer
Astex Pharmaceuticals, Inc.
 1999-09 PHASE2
NCT00005875 COMPLETED
Melanoma (Skin)
Astex Pharmaceuticals, Inc.
 1999-01 PHASE2
NCT00059917 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Memorial Sloan Kettering Cancer Center
 2003-01 PHASE1
NCT00079950 SUSPENDED
Sarcoma, Soft Tissue
Enzon Pharmaceuticals, Inc.
 2003-08 PHASE2
NCT00004076 UNKNOWN
Unspecified Adult Solid Tumor, Protocol Specific
University of Glasgow
 1999-06 PHASE1
NCT00080002 TERMINATED
Cancer of Stomach; Gastroesophageal Cancer
Enzon Pharmaceuticals, Inc.
 2003-12 PHASE2
NCT00005876 UNKNOWN
Esophageal Cancer; Gastric Cancer
Astex Pharmaceuticals, Inc.
 2000-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-20)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Camptothecin selectively binds to the DNA-topoisomerase I cleavage complex, preventing the religation of single-stranded DNA breaks during transcription and replication to induce double-stranded DNA damage and trigger cell death via apoptotic pathways. This cytotoxicity suppresses tumor cell proliferation and drives regression in topoisomerase I-dependent malignancies, providing the mechanistic rationale for its therapeutic evaluation in clinical trials targeting gastric, pancreatic, lung, and colorectal cancers.

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>).

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Note: Technical data last updated: Sep 1, 2026.