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

Nordic Pancreatic Cancer Trial (NorPACT) - 1

Phase 2

Active, not recruiting

Conditions: Pancreatic Cancer

Interventions: Procedure: Pancreatic surgery
Drug: 5-FU
Drug: Oxaliplatine
Drug: Irinotecan

First Posted Date: 2016-09-29

Last Posted Date: 2024-11-20

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 140

Registration Number: NCT02919787

Locations: 🇩🇰
Odense University Hospital, Odense, Denmark
🇫🇮
Helsinki University Hospital, Helsinki, Finland
🇳🇴
Haukeland University Hospital, Bergen, Norway

and more 10 locations

Study of Irinotecan and AZD1775, a Selective Wee 1 Inhibitor, in RAS or BRAF Mutated, Second-line Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: AZD1775
Drug: Irinotecan

First Posted Date: 2016-09-19

Last Posted Date: 2020-10-12

Lead Sponsor: NYU Langone Health

Target Recruit Count: 7

Registration Number: NCT02906059

Locations: 🇺🇸
Laura and Isaac Perlmutter Cancer Center, New York, New York, United States

Ascorbic Acid and Combination Chemotherapy in Treating Patients With Locally Advanced or Recurrent Pancreatic Cancer That Cannot Be Removed by Surgery

Early Phase 1

Completed

Conditions: Unresectable Pancreatic Carcinoma
Stage III Pancreatic Cancer
Pancreatic Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer

Interventions: Drug: Oxaliplatin
Drug: Irinotecan Hydrochloride
Drug: Leucovorin Calcium
Drug: Fluorouracil
Dietary Supplement: Ascorbic Acid

First Posted Date: 2016-09-12

Last Posted Date: 2020-01-18

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 8

Registration Number: NCT02896907

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Pancreatic Adenocarcinoma
Recurrent Pancreatic Carcinoma
Stage IV Pancreatic Cancer AJCC v6 and v7

Interventions: Drug: Fluorouracil
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Veliparib

First Posted Date: 2016-09-07

Last Posted Date: 2024-12-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 123

Registration Number: NCT02890355

Locations: 🇺🇸
Katmai Oncology Group, Anchorage, Alaska, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States
🇺🇸
CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, United States

and more 781 locations

Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

Phase 3

Recruiting

Conditions: Colorectal Neoplasms

Interventions: Drug: Oxaliplatin intravenous
Drug: 5 FU bolus
Drug: Folinic acid
Drug: Oxaliplatin intra-arteriel
Drug: Panitumumab
Drug: Bevacizumab
Drug: Irinotecan
Drug: 5 FU continuous

First Posted Date: 2016-08-31

Last Posted Date: 2023-08-18

Lead Sponsor: Federation Francophone de Cancerologie Digestive

Target Recruit Count: 348

Registration Number: NCT02885753

Locations: 🇫🇷
Hôpital André Mignot, Le Chesnay, France
🇫🇷
Hôpital Belle Isle, Metz, France
🇫🇷
CHR, Orleans, France

and more 82 locations

De-escalation Chemotherapies Versus Escalation in Non Pre-treated Unresectable Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Colorectal Neoplasms

Interventions: Drug: 5 FLUOROURACYL
Drug: acide folinique
Drug: irinotecan
Drug: Oxaliplatin
Drug: capécitabine
Drug: bevacizumab

First Posted Date: 2016-07-25

Last Posted Date: 2024-07-10

Lead Sponsor: Federation Francophone de Cancerologie Digestive

Target Recruit Count: 21

Registration Number: NCT02842580

Locations: 🇫🇷
CHU Robert DEBRE, Reims, France
🇫🇷
Ch de Cholet - Service Maladies de L4Appareil Digestif Du Dr Kaasis, Cholet, France
🇫🇷
Chd Vendee - Service D'Hge, La Roche-sur-Yon, France

and more 8 locations

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Phase 1

Recruiting

Conditions: Pediatric Cancer

First Posted Date: 2016-06-24

Last Posted Date: 2025-01-10

Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Target Recruit Count: 455

Registration Number: NCT02813135

Locations: 🇫🇷
CHU Angers, Angers, France
🇫🇷
Centre Léon Bérard, Lyon, France
🇫🇷
CHU Pellegrin, Bordeaux, France

and more 18 locations

RRx-001 in Combination With Irinotecan in Metastatic or Advanced Cancer (PAYLOAD)

Phase 1

Terminated

Conditions: Metastatic Cancer
Malignant Solid Tumor
Advanced Cancer

Interventions: Drug: RRx-001
Drug: Irinotecan

First Posted Date: 2016-06-15

Last Posted Date: 2022-05-17

Lead Sponsor: EpicentRx, Inc.

Target Recruit Count: 28

Registration Number: NCT02801097

Locations: 🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
University of California, Davis, Sacramento, California, United States

A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Phase 3

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Napabucasin
Drug: Fluorouracil
Drug: Leucovorin
Drug: Irinotecan
Drug: Bevacizumab

First Posted Date: 2016-04-27

Last Posted Date: 2023-11-15

Lead Sponsor: Sumitomo Pharma America, Inc.

Target Recruit Count: 1253

Registration Number: NCT02753127

Locations: 🇺🇸
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
🇺🇸
Dana Farber, Boston, Massachusetts, United States
🇨🇦
University of Toronto - Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

and more 204 locations

Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors With Sorafenib in Combination With Irinotecan

Phase 2

Withdrawn

Conditions: Pediatric Solid Tumors

Interventions: Drug: Sorafenib
Drug: Irinotecan

First Posted Date: 2016-04-21

Last Posted Date: 2019-09-09

Lead Sponsor: Washington University School of Medicine

Registration Number: NCT02747537

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