Numerous clinical trials spanning phase 1, phase 2, and phase 3 have evaluated fenretinide across various conditions, including T-cell lymphoma, ovarian carcinoma, head and neck cancer, and cystic fibrosis. Sponsored by academic medical centers and industry partners such as SciTech Development LLC and M.D. Anderson Cancer Center, these studies encompass completed, recruiting, and terminated statuses. Specific protocols have focused on assessing safety in relapsed T-cell lymphomas and evaluating oral dosing in adult cystic fibrosis.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06922539 | RECRUITING | Small Cell Lung Cancer |
SciTech Development, Inc. |
2025-12-11 | PHASE1 |
| NCT04234048 | RECRUITING | T-cell Lymphoma; Cutaneous/Peripheral T-Cell Lymphoma; Peripheral T-cell Lymphoma; Peripheral T-Cell Lymphoma, Not Classified; Primary Cutaneous T-cell Lymphoma; Cutaneous T-Cell Lymphoma, Unspecified; Cutaneous T-cell Lymphoma; Follicular T-Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Sézary's Disease; Mycosis Fungoides |
SciTech Development, Inc. |
2023-12-18 | PHASE1 |
| NCT07149220 | ACTIVE_NOT_RECRUITING | Oral Leukoplakia; Oral Dysplasia |
Ohio State University Comprehensive Cancer Center |
2025-10-14 | PHASE1 |
| NCT06528457 | COMPLETED | Dengue |
Island Pharmaceuticals |
2024-09-05 | PHASE2 |
| NCT06181760 | COMPLETED | Safety and Tolerability |
Island Pharmaceuticals |
2023-11-22 | PHASE1 |
| NCT04234048 | Recruiting | T-cell Lymphoma|Cutaneous/Peripheral T-Cell Lymphoma|Peripheral T-cell Lymphoma|Peripheral T-Cell Lymphoma Not Classified|Primary Cutaneous T-cell Lymphoma|Cutaneous T-Cell Lymphoma Unspecified|Cutaneous T-cell Lymphoma|Follicular T-Cell Lymphoma|Angioimmunoblastic T-cell Lymphoma|Sézary''s Disease|Mycosis Fungoides |
SciTech Development LLC |
2023-12-18 | Phase 1 |
| NCT06181760 | Completed | Safety and Tolerability |
Island Pharmaceuticals|Beyond Drug Development |
2023-11-22 | Phase 1 |
| NCT02495415 | UNKNOWN | Peripheral T-cell Lymphoma |
CerRx, Inc. |
2016-12 | PHASE2 |
| NCT01553071 | TERMINATED | Solid Tumor |
South Plains Oncology Consortium |
2016-11 | PHASE1 |
| NCT02163356 | TERMINATED | Recurrent Neuroblastoma; Neuroblastoma |
South Plains Oncology Consortium |
2014-05 | PHASE1 |
| NCT01187810 | TERMINATED | Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma |
South Plains Oncology Consortium |
2010-08 | PHASE1 |
| NCT01535157 | TERMINATED | Ovarian Cancer; Cancer of Ovary; Cancer of the Ovary; Ovary Neoplasms; Primary Peritoneal Carcinoma |
South Plains Oncology Consortium |
2012-02 | PHASE1; PHASE2 |
| NCT00104923 | COMPLETED | Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm |
California Cancer Consortium |
2005-02 | PHASE1 |
| NCT01553071 | Terminated | Solid Tumor |
South Plains Oncology Consortium |
2016-11 | Phase 1 |
| NCT01479192 | TERMINATED | High-Risk Cancer |
European Institute of Oncology |
2009-12 | PHASE3 |
| NCT02141958 | COMPLETED | Cystic Fibrosis |
Elias Matouk |
2014-04 | PHASE1 |
| NCT02141958 | Completed | Cystic Fibrosis |
Elias Matouk|McGill University Health Centre/Research Institute of the McGill University Health Centre |
2014-04 | Phase 1 |
| NCT00295919 | COMPLETED | Neuroblastoma |
New Approaches to Neuroblastoma Therapy Consortium |
2005-12 | PHASE1 |
| NCT00387504 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
California Cancer Consortium |
2006-11 | PHASE1 |
| NCT00288067 | TERMINATED | Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma; B-cell Chronic Lymphocytic Leukemia; Contiguous Stage II Adult Burkitt Lymphoma; Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Contiguous Stage II Adult Lymphoblastic Lymphoma; Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Stage II Marginal Zone Lymphoma; Stage II Small Lymphocytic Lymphoma; Extranodal Marginal Zone B-cell Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; 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; Splenic Marginal Zone Lymphoma; Stage I Adult Burkitt Lymphoma; Stage I Adult Diffuse Large Cell Lymphoma; Stage I Adult Hodgkin Lymphoma; Stage I Adult Lymphoblastic Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Small Lymphocytic Lymphoma; Stage II Adult Hodgkin Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Lymphoblastic Lymphoma; 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 Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Lymphoblastic 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; Waldenström Macroglobulinemia |
National Cancer Institute (NCI) |
2005-10 | PHASE1; PHASE2 |
| NCT00646230 | COMPLETED | Neuroblastoma |
New Approaches to Neuroblastoma Therapy Consortium |
2006-12 | PHASE1 |
| NCT01535157 | Terminated | Ovarian Cancer|Cancer of Ovary|Cancer of the Ovary|Ovary Neoplasms|Primary Peritoneal Carcinoma |
South Plains Oncology Consortium |
2012-02 | Phase 1|Phase 2 |
| NCT00546455 | SUSPENDED | Obesity; Insulin Resistance |
University of California, San Diego |
2007-12 | PHASE2 |
| NCT00077402 | COMPLETED | Prostate Cancer |
Cancer Therapeutics Research Group |
2003-11 | PHASE2 |
| NCT00589381 | COMPLETED | Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific |
National Institutes of Health Clinical Center (CC) |
2007-08 | PHASE1 |
| NCT00429936 | COMPLETED | Geographic Atrophy; Dry Age Related Macular Degeneration |
Sirion Therapeutics, Inc. |
2006-12 | PHASE2 |
| NCT00080899 | COMPLETED | Adenocarcinoma of the Prostate; Recurrent Prostate Cancer |
National Cancer Institute (NCI) |
2004-06 | PHASE2 |
| NCT00003250 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Barbara Ann Karmanos Cancer Institute |
1998-05 | PHASE1 |
| NCT00017134 | TERMINATED | Ovarian Cancer |
Gynecologic Oncology Group |
2002-09 | |
| NCT00098800 | COMPLETED | brca1 Mutation Carrier; brca2 Mutation Carrier; Ovarian Cancer |
University of Arizona |
2004-10 | |
| NCT00053326 | COMPLETED | Recurrent Neuroblastoma |
National Cancer Institute (NCI) |
2003-05 | PHASE2 |
| NCT00102635 | TERMINATED | Head and Neck Cancer |
M.D. Anderson Cancer Center |
2005-01-20 | PHASE1 |
| NCT00011973 | COMPLETED | Kidney Cancer |
Barbara Ann Karmanos Cancer Institute |
2000-12 | PHASE2 |
| NCT00009971 | COMPLETED | Lung Cancer |
National Cancer Institute (NCI) |
2000-11 | PHASE2 |
| NCT00005819 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
Case Comprehensive Cancer Center |
2000-04 | PHASE1 |
| NCT00004154 | COMPLETED | Bladder Cancer |
M.D. Anderson Cancer Center |
1998-07-30 | PHASE3 |
| NCT00075491 | TERMINATED | Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor |
National Cancer Institute (NCI) |
2003-12 | PHASE2 |
| NCT00003191 | COMPLETED | Neuroblastoma; Unspecified Childhood Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
1998-03 | PHASE1 |
| NCT00006080 | COMPLETED | Brain and Central Nervous System Tumors |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2000-09-25 | PHASE2 |
| NCT00006471 | COMPLETED | Head and Neck Cancer |
M.D. Anderson Cancer Center |
2000-09 | PHASE2 |
| NCT00026091 | COMPLETED | Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Primary Peritoneal Cavity Cancer |
National Cancer Institute (NCI) |
2001-09 | PHASE2 |
| NCT00002646 | COMPLETED | Breast Cancer |
Eastern Cooperative Oncology Group |
1995-10 | PHASE3 |
| NCT00004161 | COMPLETED | Head and Neck Cancer |
University of Alabama at Birmingham |
1997-06 | PHASE2 |
| NCT00003075 | COMPLETED | Cervical Cancer; Precancerous Condition |
M.D. Anderson Cancer Center |
1993-03-05 | PHASE3 |
| NCT00003099 | COMPLETED | Breast Cancer |
M.D. Anderson Cancer Center |
1996-05 | PHASE2 |
| NCT00003223 | TERMINATED | Head and Neck Cancer |
SWOG Cancer Research Network |
1997-12 | PHASE2 |
| NCT00003601 | COMPLETED | Melanoma (Skin) |
Eastern Cooperative Oncology Group |
1999-02-23 | PHASE2 |
| NCT00534898 | WITHDRAWN | Schizophrenia; Schizoaffective Disorder; Cognition |
Beersheva Mental Health Center |
PHASE3 | |
| NCT00009932 | UNKNOWN | Unspecified Adult Solid Tumor, Protocol Specific |
Ohio State University Comprehensive Cancer Center |
2001-01 | PHASE1 |
| NCT00001378 | COMPLETED | Breast Cancer; Breast Neoplasms |
National Cancer Institute (NCI) |
1994-01 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-08-19)
Check the
Fenretinide
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.