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

Standard and High Dose Irinotecan Based on UGT1A1 Genotype for First-line Treatment of Locally Advanced Colon Cancer

Phase 2

Conditions: Colonic Neoplasms

Interventions: Drug: Irinotecan

First Posted Date: 2013-04-08

Last Posted Date: 2013-04-08

Lead Sponsor: Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences

Target Recruit Count: 100

Registration Number: NCT01826396

Locations: 🇨🇳
Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences, Harbin, Heilongjiang, China

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

Phase 1

Completed

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: LJM716
Drug: Paclitaxel
Drug: BYL719
Drug: Docetaxel
Drug: Irinotecan

First Posted Date: 2013-04-02

Last Posted Date: 2020-12-19

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 48

Registration Number: NCT01822613

Locations: 🇬🇧
Novartis Investigative Site, Manchester, United Kingdom
🇺🇸
University of Chicago Medical Center Dept of Onc, Chicago, Illinois, United States
🇺🇸
Karmanos Cancer Institute Dept of Onc, Detroit, Michigan, United States

and more 1 locations

Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients With Pancreatic Cancer

Early Phase 1

Completed

Conditions: Acinar Cell Adenocarcinoma of the Pancreas
Duct Cell Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Pancreatic Cancer

Interventions: Drug: oxaliplatin
Drug: irinotecan
Drug: leucovorin
Drug: 5-fluorouracil
Drug: capecitabine
Radiation: radiation
Procedure: surgery
Drug: gemcitabine

First Posted Date: 2013-04-01

Last Posted Date: 2018-09-04

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 23

Registration Number: NCT01821612

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States

and more 11 locations

Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab

Phase 2

Conditions: Mucinous Adenocarcinoma of the Rectum
Recurrent Colon Cancer
Recurrent Rectal Cancer
Mucinous Adenocarcinoma of the Colon
Signet Ring Adenocarcinoma of the Colon
Signet Ring Adenocarcinoma of the Rectum
Stage IV Colon Cancer
Stage IV Rectal Cancer

Interventions: Biological: panitumumab
Drug: irinotecan hydrochloride
Drug: fluorouracil
Drug: leucovorin calcium

First Posted Date: 2013-03-20

Last Posted Date: 2019-03-27

Lead Sponsor: John Hays

Target Recruit Count: 16

Registration Number: NCT01814501

Locations: 🇺🇸
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junction Cancer

Phase 3

Terminated

Conditions: Gastroesophageal Junction Cancer
Gastric Cancer

Interventions: Drug: Irinotecan
Drug: Nimotuzumab

First Posted Date: 2013-03-18

Last Posted Date: 2018-03-26

Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.

Target Recruit Count: 400

Registration Number: NCT01813253

Locations: 🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
🇰🇷
Hwansun Junnam hospital, Gwangju, Korea, Republic of

Study to Evaluate the Safety and Tolerability of Andecaliximab as Monotherapy and in Combination With Chemotherapy in Participants With Advanced Solid Tumors

Phase 1

Completed

Conditions: Pancreatic Cancer
Esophagogastric Cancer
Non-small Cell Lung Cancer
Breast Cancer
Colorectal Cancer

Interventions: Drug: Andecaliximab
Drug: Gemcitabine
Drug: Carboplatin
Drug: Leucovorin
Drug: Nab-paclitaxel
Drug: Pemetrexed
Drug: Paclitaxel
Drug: Oxaliplatin
Drug: 5-FU
Drug: Bevacizumab
Drug: Irinotecan

First Posted Date: 2013-03-04

Last Posted Date: 2020-06-02

Lead Sponsor: Gilead Sciences

Target Recruit Count: 236

Registration Number: NCT01803282

Locations: 🇺🇸
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
🇺🇸
University of Southern California (USC), Los Angeles, California, United States
🇺🇸
Parkview Research Center, Fort Wayne, Indiana, United States

and more 15 locations

Cetuximab/FOLFIRI With or Without Oxaliplatin and FOLFOXIRI With or Without Bevacizumab in Neoadjuvant Treatment of Non-resectable Colorectal Liver Metastases

Phase 2

Conditions: Colorectal Cancer

Interventions: Drug: Cetuximab
Drug: Bevacizumab
Drug: Irinotecan
Drug: 5-FU
Drug: Oxaliplatin
Drug: Folinic Acid

First Posted Date: 2013-03-01

Last Posted Date: 2019-09-11

Lead Sponsor: Technische Universität Dresden

Target Recruit Count: 91

Registration Number: NCT01802645

Locations: 🇩🇪
Klinikum Coburg GmbH, Coburg, Germany
🇩🇪
Klinikum Landshut gGmbH, Landshut, Germany
🇩🇪
Rems-Murr-Klinikum Winnenden, Winnenden, Germany

and more 12 locations

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

Phase 1

Active, not recruiting

Conditions: Unresectable Solid Neoplasm
Metastatic Malignant Solid Neoplasm
Stage IV Colorectal Cancer AJCC v7
Stage IVA Colorectal Cancer AJCC v7
BRAF NP_004324.2:p.V600X
Stage IVB Colorectal Cancer AJCC v7
KRAS wt Allele

Interventions: Biological: Cetuximab
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Vemurafenib

First Posted Date: 2013-02-08

Last Posted Date: 2024-03-20

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 33

Registration Number: NCT01787500

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Irinotecan Hydrochloride and Temozolomide With Temsirolimus or Dinutuximab in Treating Younger Patients With Refractory or Relapsed Neuroblastoma

Phase 2

Completed

Conditions: Ganglioneuroblastoma
Recurrent Neuroblastoma

Interventions: Drug: Irinotecan Hydrochloride
Biological: Dinutuximab
Other: Laboratory Biomarker Analysis
Drug: Temozolomide
Biological: Sargramostim
Drug: Temsirolimus

First Posted Date: 2013-01-14

Last Posted Date: 2022-10-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 73

Registration Number: NCT01767194

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Nationwide Children's Hospital, Columbus, Ohio, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

and more 154 locations

Sequential and Concurrent FOLFOXIRI/Bevacizumab Regimens Versus FOLFOX/Bevacizumab in First-Line Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Neoplasms

Interventions: Drug: 5-fluorouracil
Drug: bevacizumab
Drug: capecitabine
Drug: irinotecan
Drug: folinic acid
Drug: oxaliplatin

First Posted Date: 2013-01-10

Last Posted Date: 2017-09-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 280

Registration Number: NCT01765582

Locations: 🇺🇸
USC Norris Cancer Center, Los Angeles, California, United States
🇺🇸
Johns Hopkins Univ; Bunting Blaustein Cancer Center, Baltimore, Maryland, United States
🇺🇸
Tufts Medical Center, Boston, Massachusetts, United States

and more 42 locations

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