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

Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF

Phase 2

Terminated

Conditions: Colorectal Cancer
Colorectal Adenocarcinoma

Interventions: Drug: Brivanib
Drug: Irinotecan

First Posted Date: 2011-06-07

Last Posted Date: 2020-09-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 8

Registration Number: NCT01367275

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer

Phase 1

Terminated

Conditions: Advanced Cancer

Interventions: Drug: PF-05212384
Drug: PD-0325901
Drug: irinotecan

First Posted Date: 2011-05-04

Last Posted Date: 2018-10-29

Lead Sponsor: Pfizer

Target Recruit Count: 105

Registration Number: NCT01347866

Locations: 🇺🇸
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
🇺🇸
UCLA Oncology Center, Los Angeles, California, United States
🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada

and more 14 locations

Safety and Pharmacokinetics of Treating Liver Cancer With Drug-Eluting Beads

Phase 1

Terminated

Conditions: Neoplasm Metastases
Melanoma
Colorectal Neoplasms

First Posted Date: 2011-04-18

Last Posted Date: 2019-12-17

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Target Recruit Count: 5

Registration Number: NCT01336985

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

Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer

Phase 2

Terminated

Conditions: Liver Metastases
Stage IVA Rectal Cancer
Stage IVB Colon Cancer
Stage IVB Rectal Cancer
Recurrent Colon Cancer
Recurrent Rectal Cancer
Stage IVA Colon Cancer

Interventions: Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: bevacizumab
Radiation: yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Other: laboratory biomarker analysis
Other: pharmacological study
Drug: irinotecan hydrochloride

First Posted Date: 2011-03-22

Last Posted Date: 2016-07-19

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 1

Registration Number: NCT01320683

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

Phase 2

Terminated

Conditions: Bone Cancer
Ewing's Sarcoma

Interventions: Drug: Irinotecan
Drug: Vincristine
Drug: Temozolomide
Drug: Doxorubicin
Drug: Cytoxan
Drug: Pegfilgrastim

First Posted Date: 2011-03-14

Last Posted Date: 2017-11-24

Lead Sponsor: Stanford University

Target Recruit Count: 3

Registration Number: NCT01313884

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

A Trial of Irinotecan and BKM120 in Previously Treated Advanced Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Irinotecan
Drug: BKM120

First Posted Date: 2011-02-25

Last Posted Date: 2017-01-06

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 20

Registration Number: NCT01304602

Locations: 🇺🇸
University of Kansas Cancer Center, Kansas City, Kansas, United States

Trial of ICM With or Without AZD2281 (Olaparib) in Patients With Advanced Pancreatic Cancer

Phase 1

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Irinotecan
Drug: Cisplatin
Drug: Olaparib (for levels 1 and 5)
Drug: Olaparib (for dose level 2)
Drug: Mitomycin-C

First Posted Date: 2011-02-15

Last Posted Date: 2016-03-22

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 18

Registration Number: NCT01296763

Locations: 🇺🇸
Columbia University Medical Center, New York, New York, United States
🇺🇸
The Johns Hopkins University School of Medicine, Baltimore, Maryland, United States

A Study of Irinotecan, Levofolinate, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab (IMC-1121B)

Phase 1

Completed

Conditions: Colorectal Carcinoma

Interventions: Biological: Ramucirumab (IMC-1121B)
Drug: Irinotecan
Drug: levofolinate
Drug: 5-Fluorouracil (5-FU)

First Posted Date: 2011-01-31

Last Posted Date: 2014-10-06

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 6

Registration Number: NCT01286818

Locations: 🇯🇵
ImClone Investigational Site, Shizuoka, Japan

Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer

Not Applicable

Terminated

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: irinotecan hydrochloride
Drug: capecitabine
Genetic: mutation analysis
Biological: bevacizumab
Biological: cetuximab
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Genetic: nucleic acid sequencing
Genetic: protein expression analysis
Genetic: polymerase chain reaction
Genetic: DNA analysis

First Posted Date: 2011-01-21

Last Posted Date: 2021-03-15

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 3

Registration Number: NCT01280643

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Study of REOLYSIN® in Combination With FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: KRAS Mutant Metastatic Colorectal Cancer

First Posted Date: 2011-01-11

Last Posted Date: 2018-12-19

Lead Sponsor: Oncolytics Biotech

Target Recruit Count: 36

Registration Number: NCT01274624

Locations: 🇺🇸
Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York, United States
🇺🇸
New York Presbyterian Hospital/ Weill Cornell Medical College, New York, New York, United States

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