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

Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma

Phase 1

Completed

Conditions: Pancreatic Adenocarcinoma

First Posted Date: 2015-12-03

Last Posted Date: 2018-09-13

Lead Sponsor: Oncolytics Biotech

Target Recruit Count: 11

Registration Number: NCT02620423

Locations: 🇺🇸
Cancer Therapy & Research Center at UTHSCSA, San Antonio, Texas, United States

Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors

Phase 1

Recruiting

Conditions: Glioblastoma
Advanced Solid Tumors
Soft Tissue Sarcoma (Excluding GIST)
Epithelial Ovarian Carcinoma
Endometrial Carcinoma
Mesothelioma
Gastroenteropancreatic Neuroendocrine Tumor
SCLC
Gastric Carcinoma
Pancreatic Adenocarcinoma

Interventions: Drug: Lurbinectedin
Drug: Irinotecan

First Posted Date: 2015-11-20

Last Posted Date: 2024-04-30

Lead Sponsor: PharmaMar

Target Recruit Count: 320

Registration Number: NCT02611024

Locations: 🇩🇪
Helios Klinikum Berlin Buch, Berlin, Germany
🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇮🇹
Campus Biomedico, Roma, Italy

and more 19 locations

Trial of Capecitabine With or Without Irinotecan Driven by UGT1A1

Phase 3

Conditions: Locally Advanced Rectal Cancer

Interventions: Radiation: Radiation
Drug: Capecitabine
Drug: Oxaliplatin
Drug: Irinotecan

First Posted Date: 2015-11-16

Last Posted Date: 2016-12-07

Lead Sponsor: Fudan University

Target Recruit Count: 360

Registration Number: NCT02605265

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Prospective Pilot Trial to Assess a Multimodal Molecular Targeted Therapy in Children, Adolescent and Young Adults With Relapsed or Refractory High-grade Pineoblastoma

Phase 2

Completed

Conditions: Pineoblastoma

Interventions: Drug: Temozolomide
Drug: Irinotecan
Drug: Dasatinib
Drug: Rapamycin

First Posted Date: 2015-11-04

Last Posted Date: 2021-08-05

Lead Sponsor: University of Regensburg

Target Recruit Count: 4

Registration Number: NCT02596828

Locations: 🇩🇪
University Hospital of Regensburg, Regensburg, Germany

M6620 and Irinotecan Hydrochloride in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Phase 1

Active, not recruiting

Conditions: Metastatic Pancreatic Carcinoma
Refractory Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v8
Refractory Colorectal Carcinoma
Metastatic Lung Small Cell Carcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Unresectable Colorectal Carcinoma
Unresectable Lung Small Cell Carcinoma

Interventions: Drug: Berzosertib
Procedure: Biopsy Specimen
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Irinotecan Hydrochloride

First Posted Date: 2015-11-04

Last Posted Date: 2024-12-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 66

Registration Number: NCT02595931

Locations: 🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States

and more 20 locations

A Study of Eribulin in Combination With Oral Irinotecan for Adolescent and Young Adult Patients With Relapsed or Refractory Solid Tumors

Phase 1

Completed

Conditions: Relapsed Solid Tumors
Refractory Solid Tumors

Interventions: Drug: Eribulin
Drug: Irinotecan
Other: Cefixime

First Posted Date: 2015-11-04

Last Posted Date: 2022-02-15

Lead Sponsor: University of Colorado, Denver

Target Recruit Count: 2

Registration Number: NCT02596503

Locations: 🇺🇸
University of Texas, Southwestern Medical Center, Dallas, Texas, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States
🇺🇸
University of Kentucky, Lexington, Kentucky, United States

Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer

Phase 1

Completed

Conditions: Advanced Solid Tumours

Interventions: Drug: AZD0156
Drug: Olaparib
Drug: irinotecan
Drug: Fluorouracil
Drug: Folinic Acid

First Posted Date: 2015-10-27

Last Posted Date: 2022-09-19

Lead Sponsor: AstraZeneca

Target Recruit Count: 84

Registration Number: NCT02588105

Locations: 🇬🇧
Research Site, Manchester, United Kingdom

A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

Phase 4

Completed

Conditions: Colorectal Cancer

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

First Posted Date: 2015-10-21

Last Posted Date: 2017-03-09

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 40

Registration Number: NCT02582970

Pan FGFR Kinase Inhibitor BGJ398 and Combination Chemotherapy in Treating Patients With Untreated Metastatic Pancreatic Cancer

Phase 1

Withdrawn

Conditions: Colon Adenocarcinoma
Metastatic Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma
Pancreatic Ductal Adenocarcinoma
Rectal Adenocarcinoma
Stage III Pancreatic Cancer
Stage IVA Rectal Cancer
Stage IIIA Colon Cancer
Stage IIIB Colon Cancer
Stage IIIC Colon Cancer

Interventions: Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Oxaliplatin
Drug: pan FGFR Kinase Inhibitor BGJ398
Other: Pharmacological Study