Irinotecan

Generic Name: Irinotecan

Brand Names: Camptosar, Onivyde, Onivyde pegylated liposomal (previously known as Onivyde)

Drug Type: Small Molecule

Chemical Formula: C_₃₃H_₃₈N_₄O_₆

CAS Number: 97682-44-5

Unique Ingredient Identifier: 7673326042

Background: Irinotecan is an antineoplastic enzyme inhibitor primarily used in the treatment of colorectal cancer. It is a derivative of camptothecin that inhibits the action of topoisomerase I. Irinotecan prevents religation of the DNA strand by binding to topoisomerase I-DNA complex, and causes double-strand DNA breakage and cell death. It is a derivative of camptothecin. Irinotecan was approved for the treatment of advanced pancreatic cancer in October, 2015 (irinotecan liposome injection, trade name Onivyde).

Indication: For the treatment of metastatic colorectal cancer (first-line therapy when administered with 5-fluorouracil and leucovorin). Also used in combination with cisplatin for the treatment of extensive small cell lung cancer. Irinotecan is currently under investigation for the treatment of metastatic or recurrent cervical cancer. Also used in combination with fluorouracil and leucovorin for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy.

Associated Conditions: Esophageal Cancer, Ewing's Sarcoma, Gastric Cancer, High Grade Glioma: Glioblastoma (GBM), Metastatic Cervical Cancer, Non-Small Cell Lung Cancer (NSCLC), Ovarian Cancer, Pancreatic Cancer, Rhabdomyosarcomas, Small Cell Lung Cancer (SCLC), Stage IV Colorectal Cancer, Recurrent, metastatic Colorectal carcinoma, Refractory, metastatic Pancreatic adenocarcinoma

Associated Therapies: -

Clinical Trials

Activity Study of Bevacizumab With Temozolomide ± Irinotecan for Neuroblastoma in Children

Phase 2

Active, not recruiting

Conditions: Neuroblastoma

Interventions: Drug: Bevacizumab
Drug: Topotecan
Drug: Irinotecan
Drug: Temozolomide
Drug: Dinutuximab Beta
Drug: Cyclophosphamide

First Posted Date: 2014-12-04

Last Posted Date: 2024-05-14

Lead Sponsor: University of Birmingham

Target Recruit Count: 225

Registration Number: NCT02308527

Locations: 🇦🇹
St Anna Children's Hospital and CCRI/Studies and Statistics, Vienna, Austria
🇩🇰
University Hospital Rigshospitalet, Copenhagen, Denmark
🇮🇹
Ospedale Pediatrico Bambino Gseu, Rome, Italy

and more 7 locations

Cetuximab Rechallenge in Irinotecan-pretreated mCRC, KRAS, NRAS and BRAF Wild-type Treated in 1st Line With Anti-EGFR Therapy (CRICKET).

Phase 2

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: cetuximab
Drug: irinotecan

First Posted Date: 2014-11-20

Last Posted Date: 2018-02-15

Lead Sponsor: Gruppo Oncologico del Nord-Ovest

Target Recruit Count: 27

Registration Number: NCT02296203

Locations: 🇮🇹
Azienda Ospedaliero Universitaria Di Parma - U.O.Oncologia Medica, Parma, Italy
🇮🇹
A.O. Universitaria S.Maria Della Misericordia Di Udine, Udine, Italy
🇮🇹
Azienda Policlinico Umberto I - Oncologia Medica, Roma, Italy

and more 6 locations

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery

Phase 2

Completed

Conditions: Colorectal Adenocarcinoma
Stage IVB Colorectal Cancer AJCC v7
RAS Wild Type
Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7

Interventions: Biological: Bevacizumab
Biological: Cetuximab
Drug: Irinotecan
Other: Placebo
Other: Laboratory Biomarker Analysis

First Posted Date: 2014-11-17

Last Posted Date: 2022-01-31

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 36

Registration Number: NCT02292758

Locations: 🇺🇸
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
🇺🇸
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
🇺🇸
Missouri Baptist Medical Center, Saint Louis, Missouri, United States

and more 10 locations

Selinexor in Combination With Irinotecan in Adenocarcinoma of Stomach and Distal Esophagus

Phase 1

Terminated

Conditions: Gastric Cancer
Esophageal Cancer

Interventions: Drug: Selinexor
Drug: Irinotecan

First Posted Date: 2014-11-05

Last Posted Date: 2016-01-15

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 3

Registration Number: NCT02283359

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC

Phase 2

Terminated

Conditions: Lung Neoplasms, Non-Small Cell Lung Cancer

Interventions: Drug: Irinotecan
Drug: Cisplatin

First Posted Date: 2014-10-27

Last Posted Date: 2019-08-21

Lead Sponsor: Leo W. Jenkins Cancer Center

Target Recruit Count: 4

Registration Number: NCT02275806

Locations: 🇺🇸
Leo W Jenkins Cancer Center, Greenville, North Carolina, United States

Escalated Dose of Irinotecan in mCRC

Not Applicable

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Genetic: UGTIA1 genotyping (7,7)
Genetic: UGT1A1 genotyping (6,6)
Genetic: UGTIA1 genotyping (6,7)
Genetic: UGT1A1 non-genotyping
Drug: bevacizumab (Avastin)
Drug: irinotecan
Drug: Leucovorin
Drug: 5-FU

First Posted Date: 2014-10-06

Last Posted Date: 2021-11-17

Lead Sponsor: Jaw-Yuan Wang, MD, PhD

Target Recruit Count: 213

Registration Number: NCT02256800

Locations: 🇨🇳
Chung-Ho Memorial Hospital, Kaohsiung Medical University:, Kaohsiung, Taiwan

A Multicenter, Clinical Study of FOLFOXIRI With Bevacizumab As First-line Therapy in Patients With mCRC

Phase 2

Completed

Conditions: Colorectal Neoplasms

Interventions: Biological: Bevacizumab
Drug: 5-fluorouracil
Drug: Irinotecan hydrochloride
Drug: Leucovorin calcium
Drug: Oxaliplatin

First Posted Date: 2014-09-22

Last Posted Date: 2017-06-19

Lead Sponsor: EPS Corporation

Target Recruit Count: 69

Registration Number: NCT02246049

Locations: 🇯🇵
EPS Corporation, Shinjuku, Tokyo, Japan

Modufolin (Arfolitixorin) in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Neoplasm

Interventions: Drug: Modufolin (arfolitixorin)
Drug: Fluorouracil
Drug: Oxaliplatin
Drug: Irinotecan
Drug: Bevacizumab

First Posted Date: 2014-09-19

Last Posted Date: 2020-09-09

Lead Sponsor: Isofol Medical AB

Target Recruit Count: 105

Registration Number: NCT02244632

Locations: 🇬🇷
251 General Airforce Hospital, Athens, Greece
🇬🇷
Metropolitan General Hospital, Athens, Greece
🇳🇴
Oslo University Hospital - Radiumhospitalet, Oslo, Norway

and more 7 locations

A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Pancreatic Cancer

Phase 1

Completed

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: BBI608
Drug: Nab-paclitaxel
Drug: Oxaliplatin
Drug: Leucovorin
Drug: Gemcitabine
Drug: Irinotecan
Drug: MM-398
Drug: Fluorouracil

First Posted Date: 2014-09-04

Last Posted Date: 2023-11-18

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 139

Registration Number: NCT02231723

Locations: 🇺🇸
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
🇺🇸
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Virginia Oncology Associates, Norfolk, Virginia, United States

and more 9 locations

Carboxylesterase-Expressing Allogeneic Neural Stem Cells and Irinotecan Hydrochloride in Treating Patients With Recurrent High-Grade Gliomas

Phase 1

Active, not recruiting

Conditions: Recurrent Anaplastic Astrocytoma
Recurrent Anaplastic Oligoastrocytoma
Recurrent Malignant Glioma
Recurrent Glioblastoma
Recurrent WHO Grade III Glioma
Recurrent Gliosarcoma
Recurrent Anaplastic Oligodendroglioma

Interventions: Biological: Carboxylesterase-expressing Allogeneic Neural Stem Cells
Drug: Irinotecan
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2014-07-16

Last Posted Date: 2024-04-29

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 18

Registration Number: NCT02192359

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy