Irinotecan: clinical trials recruiting now
38
Recruiting trials
15
Conditions studied
45
US states with sites
32
Countries
FDA drug label
- FDA-approved
- Yes. Irinotecan appears in the FDA drug-label database. Marketed as Irinotecan hydrochloride.
- Boxed warning
- The FDA label for 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
Phase 1 16
Phase 2 14
Phase 3 12
Not applicable 1
Conditions being studied
Recruiting trials involving Irinotecan
- 5FU/LV, Irinotecan, Temozolomide and Bevacizumab for MGMT Silenced, Microsatellite Stable Metastatic Colorectal Cancer.
- A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI
- A Phase II Study of AMT-676 Combination Therapies in Advanced Colorectal Cancer
- A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
- A Study of ASP1002 in Adults for Treatment of Solid Tumors
- A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
- A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer
- A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer
- A Study of Amivantamab and FOLFIRI Versus Cetuximab/Bevacizumab and FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Colorectal Cancer Who Have Previously Received Chemotherapy
- A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
- A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
- AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic Cancer
- AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
- AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
- Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
- Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer
- Efficacy of Hyperthermic Intraperitoneal Chemotherapy
- FOLFOX Via HAI Plus Intravenous Irinotecan With or Without Bevacizumab Versus Systemic FOLFOXIRI With or Without Bevacizumab in Initially Unresectable RAS-mutated CRLM Patients
- GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
- Intermittent or Continuous Panitumumab Plus FOLFIRI for Left Sided RAS/B-RAF Wild-type Metastatic Colorectal Cancer
- Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
- MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer
- MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
- NC410 and FOLFIRINOX in Combination With Nivolumab With or Without Ipilimumab in Patients With Untreated Metastatic Pancreatic Cancer
- PIPAC for the Treatment of Peritoneal Carcinomatosis in Patients With Ovarian, Uterine, Appendiceal, Colorectal, or Gastric Cancer
- Pegcetacoplan in Combination With Modified FOLFIRINOX for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma
- Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
- Safety of Combining Irinotecan With 5-FU, Leucovorin/Folinic Acid, Oxaliplatin, and Docetaxel Chemotherapies
- Small Cell Lung Cancer Irinotecan and CDC2-like Kinase Inhibition Trial (SLICK Trial)
- Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
- Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)
- Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
- Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations
- Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver
- Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
- The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer
- ValproIc Acid to Potentiate Anti-EGFR Treatment Efficacy and Prevent/Revert Resistance in Colorectal Cancer
Common questions
Is Irinotecan FDA-approved?
Yes, marketed as Irinotecan hydrochloride. Its FDA label carries a boxed warning.
How many recruiting trials involve Irinotecan?
38 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.