liposomal irinotecan: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. liposomal irinotecan appears in the FDA drug-label database. Marketed as Irinotecan hydrochloride.
- Boxed warning
- The FDA label for liposomal irinotecan carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum, ( 1 ) • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim. — West-Ward Pharmaceutical Corp. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-09-23 |
| Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim. — West-Ward Pharmaceutical Corp. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2013-09-23 |
| Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. — Hikma Pharmaceuticals USA Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-06-11 |
| Superpotent Drug: High out of specification assay value results for potency. — Ingenus Pharmaceuticals Llc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-06-08 |
| Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. — Hikma Pharmaceuticals USA Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2020-06-11 |
Phase breakdown
Conditions being studied
| Condition | Trials |
|---|---|
| Colorectal Cancer | 2 |
| Metastatic Pancreatic Adenocarcinoma | 1 |
| Metastatic Pancreatic Cancer | 1 |
| Pancreatic Cancer | 1 |
| Rectal Cancer, Adenocarcinoma | 1 |
Recruiting trials involving liposomal irinotecan
- A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
- Liposomal Irinotecan and Leucovorin/5-fluorouracil Plus Bevacizumab in Metastatic Colorectal Cancer
- SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC
Common questions
Is liposomal irinotecan FDA-approved?
Yes, marketed as Irinotecan hydrochloride. Its FDA label carries a boxed warning.
How many recruiting trials involve liposomal irinotecan?
3 recruiting trials across 5 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.