Doxorubicin: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Doxorubicin appears in the FDA drug-label database. Marketed as Doxorubicin Hydrochloride.
- Boxed warning
- The FDA label for Doxorubicin carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Doxorubicin Hydrochloride Injection is an anthracycline topoisomerase inhibitor indicated: • as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer ( 1.1 ) • for the treatment of: acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin lymphoma, Non-Hodgkin lymphoma, metastatic breast cancer, metastatic Wilms' tumor, metastatic neuroblastoma, metastatic soft tissue sarcoma, metastatic bone sarcomas, metastatic ovarian carcinoma, metastatic transitional cell bladder carcinoma, metastatic thyroid carcinoma, metastatic gastric carcinoma, metastatic bronchogenic carcinoma ( 1.2 ) 1.1 Adjuvant Breast Cancer Doxorubicin Hydrochloride Injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer . 1.2 Other Cancers Doxorubicin Hydrochloride Injection is indicated for the treatment of • acute lymphoblastic leukemia • acute myeloblastic leukemia • Hodgkin lymphoma • non-Hodgkin lymphoma (NHL) • metastatic breast cancer • metastatic Wilms' tumor • metastatic neurob…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Cross Contamination with Other Products: trace amounts of octreotide found during testing — Fresenius Kabi USA, LLC | Class III (FDA: unlikely to cause harm) | Terminated | 2020-11-17 |
| CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake. — Baxter Healthcare Corporation | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2023-08-24 |
| Presence of Particulate matter: Particulate matter identified as glass. — SUN PHARMACEUTICAL INDUSTRIES INC | Class I (FDA: reasonable probability of serious harm or death) | Ongoing | 2026-05-12 |
| Lack Of Assurance Of Sterility — Sun Pharmaceutical Industries, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-01-16 |
Phase breakdown
Conditions being studied
Recruiting trials involving Doxorubicin
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
- A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
- A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma
- A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
- Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
- In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
- Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC
- Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
- PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
- PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
- Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
- Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas
- Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
- Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
- Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer
- The CARDIOPROTECT Trial
- Using Tumor Models to Determine Treatments
Common questions
Is Doxorubicin FDA-approved?
Yes, marketed as Doxorubicin Hydrochloride. Its FDA label carries a boxed warning.
How many recruiting trials involve Doxorubicin?
18 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.