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

Gemcitabine Plus Erlotinib in RASH-positive Patients With Metastatic Pancreatic Cancer

Phase 2

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Erlotinib
Drug: Folinic Acid
Drug: Irinotecan
Drug: 5-FU

First Posted Date: 2012-11-20

Last Posted Date: 2017-07-19

Lead Sponsor: Ludwig-Maximilians - University of Munich

Target Recruit Count: 150

Registration Number: NCT01729481

Locations: 🇩🇪
University of Munich, Munich, Germany

Intra-arterial Hepatic Bevacizumab and Systemic Chemotherapy

Phase 2

Completed

Conditions: Colorectal Neoplasms

Interventions: Drug: Bevacizumab
Drug: Capecitabine
Drug: Irinotecan

First Posted Date: 2012-09-03

Last Posted Date: 2016-06-09

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 10

Registration Number: NCT01677884

Locations: 🇫🇷
Institut Gustave Roussy, Villejuif, Val de Marne, France

ISIS 183750 With Irinotecan for Advanced Solid Tumors or Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumors

Interventions: Drug: ISIS 183750
Drug: Irinotecan

First Posted Date: 2012-08-29

Last Posted Date: 2016-04-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT01675128

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Colorectal Cancer Metastatic

Phase 3

Completed

Conditions: Colorectal Cancer Metastatic

Interventions: Drug: AFLIBERCEPT
Drug: Irinotecan
Drug: Fluorouracil
Drug: Leucovorin

First Posted Date: 2012-08-22

Last Posted Date: 2016-11-28

Lead Sponsor: Sanofi

Target Recruit Count: 175

Registration Number: NCT01670721

Locations: 🇫🇷
Administrative office, Paris, France

A Pilot Study of Pre- and Post-surgery Chemotherapy With mFOLFIRINOX in Localized, Resectable Pancreatic Adenocarcinoma

Phase 2

Completed

Conditions: Pancreatic Adenocarcinoma

Interventions: Drug: 5 Fluorouracil
Drug: Leucovorin
Drug: Irinotecan
Drug: Oxaliplatin

First Posted Date: 2012-08-09

Last Posted Date: 2021-11-08

Lead Sponsor: NorthShore University HealthSystem

Target Recruit Count: 22

Registration Number: NCT01660711

Locations: 🇺🇸
NorthShore University HealthSystem, Evanston, Illinois, United States

A Protocol of Irinotecan for Carcinoma of the Lung

Phase 2

Withdrawn

Conditions: Lung Cancer

Interventions: Drug: Irinotecan

First Posted Date: 2012-07-31

Last Posted Date: 2014-05-30

Lead Sponsor: Susanne Arnold

Registration Number: NCT01654081

Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: 5-Fluorouracil (5FU)
Drug: Paclitaxel
Drug: Carboplatin
Drug: Leucovorin
Drug: Irinotecan
Drug: BMS-906024

First Posted Date: 2012-07-31

Last Posted Date: 2020-01-28

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 141

Registration Number: NCT01653470

Locations: 🇺🇸
Usc/Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇨🇦
Local Institution, Ottawa, Quebec, Canada

Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: 5-fluorouracil
Drug: Cetuximab
Drug: Irinotecan
Drug: MEHD7945A
Drug: Leucovorin

First Posted Date: 2012-07-30

Last Posted Date: 2016-11-02

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 135

Registration Number: NCT01652482

Bevacizumab And Combination Chemotherapy in Rectal Cancer Until Surgery

Phase 2

Completed

Conditions: Rectal Cancer

Interventions: Biological: Bevacizumab
Drug: Oxaliplatin
Drug: Irinotecan
Drug: 5-Fluorouracil

First Posted Date: 2012-07-26

Last Posted Date: 2019-10-07

Lead Sponsor: University College, London

Target Recruit Count: 20

Registration Number: NCT01650428

Locations: 🇬🇧
Wexham Park Hospital, Slough, United Kingdom
🇬🇧
UCLH, London, United Kingdom
🇬🇧
Blackpool Victoria Hospital, Blackpool, United Kingdom

and more 8 locations

Genotype-guided Dosing of mFOLFIRINOX Chemotherapy in Patients With Previously Untreated Advanced Gastrointestinal Malignancies

Phase 1

Completed

Conditions: Adenocarcinoma of the Gallbladder
Adenocarcinoma of Unknown Primary
Adult Primary Cholangiocellular Carcinoma
Advanced Adult Primary Liver Cancer
Cholangiocarcinoma of the Extrahepatic Bile Duct
Acinar Cell Adenocarcinoma of the Pancreas
Cholangiocarcinoma of the Gallbladder
Diffuse Adenocarcinoma of the Stomach
Duct Cell Adenocarcinoma of the Pancreas
Intestinal Adenocarcinoma of the Stomach

Interventions: Drug: oxaliplatin
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: fluorouracil
Other: laboratory biomarker analysis

First Posted Date: 2012-07-18

Last Posted Date: 2020-05-08

Lead Sponsor: University of Chicago

Target Recruit Count: 79

Registration Number: NCT01643499

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Evanston CCOP-NorthShore University HealthSystem, Evanston, Illinois, United States

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