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

Randomized Multicenter Phase II/III Study With Adjuvant Gemcitabine Versus Neoadjuvant / Adjuvant FOLFIRINOX for Resectable Pancreas Carcinoma

Phase 2

Completed

Conditions: Resectable Prancreas Carcinoma

Interventions: Drug: Oxaliplatin
Drug: Gemcitabine
Drug: 5-Fluorouracil
Drug: Irinotecan
Drug: Natriumfolinate

First Posted Date: 2014-06-24

Last Posted Date: 2020-09-02

Lead Sponsor: Krankenhaus Nordwest

Target Recruit Count: 40

Registration Number: NCT02172976

Locations: 🇩🇪
Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany, Frankfurt, Germany

Study of Different Doses of Irinotecan and Cisplatin for First-line Extensive-stage Small-cell Lung Cancer Treatment

Phase 2

Conditions: Small Cell Lung Cancer

Interventions: Drug: irinotecan

First Posted Date: 2014-06-24

Last Posted Date: 2021-02-03

Lead Sponsor: Guangdong Association of Clinical Trials

Target Recruit Count: 54

Registration Number: NCT02171325

Locations: 🇨🇳
Jilin cancer hospital, Changchun, Jilin, China

S1406 Phase II Study of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF Mutant Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: cetuximab
Drug: irinotecan hydrochloride
Drug: vemurafenib

First Posted Date: 2014-06-17

Last Posted Date: 2020-12-30

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 106

Registration Number: NCT02164916

Locations: 🇺🇸
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center, Maumee, Ohio, United States
🇺🇸
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States

and more 756 locations

M6620 First in Human Study

Phase 1

Completed

Conditions: Advanced Solid Tumor

Interventions: Drug: M6620
Drug: Gemcitabine
Drug: Irinotecan
Drug: Cisplatin
Drug: Etoposide
Drug: Carboplatin

First Posted Date: 2014-06-06

Last Posted Date: 2020-04-01

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Target Recruit Count: 200

Registration Number: NCT02157792

Locations: 🇺🇸
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Long Island Jewish Medical Center - Monter Cancer Center, Lake Success, New York, United States

and more 27 locations

Efficacy and Tolerance Evaluation in FOLFIRINOX Dose Adjusted in Elderly Patients With a Metastatic Pancreatic Cancer

Phase 2

Completed

Conditions: Pancreatic Metastatic Cancer
Toxicity

Interventions: Drug: Oxaliplatine
Drug: Folinic acid
Drug: Irinotecan
Drug: 5-FU

First Posted Date: 2014-05-21

Last Posted Date: 2022-07-28

Lead Sponsor: Institut Cancerologie de l'Ouest

Target Recruit Count: 72

Registration Number: NCT02143219

Locations: 🇫🇷
ICO Paul Papin, Angers, France
🇫🇷
CH Vendée, La Roche Sur Yon, France
🇫🇷
Centre Oscar Lambret, Lille, France

and more 3 locations

Genotype-Directed Study Of Irinotecan Dosing In FOLFIRI + BevacizumabTreated Metastatic Colorectal Cancer

Phase 2

Active, not recruiting

Conditions: Colon Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Leucovorin
Drug: Irinotecan
Drug: Bevacizumab

First Posted Date: 2014-05-14

Last Posted Date: 2023-09-14

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 100

Registration Number: NCT02138617

Locations: 🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States
🇺🇸
IU Simon Cancer Center, Indianapolis, Indiana, United States
🇺🇸
Carolina Healthcare Systems, Charlotte, North Carolina, United States

and more 4 locations

Clinical Trial of Combination Chemotherapy With Aflibercept in Patients With Advanced Colorectal Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: AFLIBERCEPT
Drug: Irinotecan
Drug: 5-Fluorouracil
Drug: Folinic Acid

First Posted Date: 2014-05-02

Last Posted Date: 2017-10-24

Lead Sponsor: Hellenic Cooperative Oncology Group

Target Recruit Count: 73

Registration Number: NCT02129257

Locations: 🇬🇷
2nd Dept of Internal Medicine, Agios Savvas Cancer Hospital, Athens, Greece
🇬🇷
2nd Dept of Internal Medicine, General Hospital of Athens "Hippokratio", Athens, Greece
🇬🇷
Dept of Medical Oncology, Ioannina University Hospital, Ioannina, Greece

and more 15 locations

Efficacy And Safety Of Xeliri + Avastin Followed By Xelox + Avastin Or Reverse Sequence In Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Capecitabine
Drug: Bevacizumab
Drug: Irinotecan
Drug: Oxaliplatin

First Posted Date: 2014-04-21

Last Posted Date: 2019-09-25

Lead Sponsor: Prof. Dr. Werner Scheithauer

Target Recruit Count: 120

Registration Number: NCT02119026

Locations: 🇦🇹
Medical University of Vienna, Vienna, Austria

A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Neoplasms

Interventions: Drug: Regorafenib
Drug: RRx-001
Drug: Irinotecan

First Posted Date: 2014-03-26

Last Posted Date: 2024-10-11

Lead Sponsor: EpicentRx, Inc.

Target Recruit Count: 62

Registration Number: NCT02096354

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸
Kaiser Permanete, Honolulu, Hawaii, United States
🇺🇸
Stanford University, Stanford, California, United States

and more 2 locations

Adavosertib and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors

Phase 1

Completed

Conditions: Primary Central Nervous System Neoplasm
Recurrent Rhabdomyosarcoma
Refractory Malignant Solid Neoplasm
Central Nervous System Ganglioneuroblastoma
Embryonal Tumor With Multilayered Rosettes, C19MC-Altered
Recurrent Childhood Central Nervous System Embryonal Neoplasm
Pineoblastoma
Refractory Medulloblastoma
Refractory Neuroblastoma
Central Nervous System Embryonal Tumor With Rhabdoid Features

Interventions: Drug: Adavosertib
Drug: Irinotecan Hydrochloride

First Posted Date: 2014-03-24

Last Posted Date: 2023-09-26

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 76

Registration Number: NCT02095132

Locations: 🇺🇸
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
🇺🇸
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
🇺🇸
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States

and more 21 locations

Drug Development Updates

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