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 Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)

Phase 1

Completed

Conditions: Neoplasms

Interventions: Biological: Favezelimab
Biological: Favezelimab/Pembrolizumab
Biological: Pembrolizumab
Drug: Oxaliplatin
Drug: Irinotecan
Drug: Lenvatinib
Drug: Leucovorin (Calcium Folinate)
Drug: Fluorouracil [5-FU]

First Posted Date: 2016-03-25

Last Posted Date: 2024-03-28

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 482

Registration Number: NCT02720068

A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer

Phase 1

Completed

Conditions: Neoplasm Metastasis

Interventions: Drug: Olaratumab
Drug: Doxorubicin
Drug: Ifosfamide
Drug: Vincristine
Drug: Irinotecan

First Posted Date: 2016-02-09

Last Posted Date: 2020-05-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 68

Registration Number: NCT02677116

Locations: 🇺🇸
St Jude Childrens Research Hospital, Memphis, Tennessee, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Childrens Hospital of Los Angeles, Los Angeles, California, United States

and more 18 locations

Irinotecan as 3rd Line Therapy in Gastric Cancer

Phase 2

Conditions: Stomach Neoplasms

Interventions: Drug: Irinotecan

First Posted Date: 2016-01-26

Last Posted Date: 2016-01-26

Lead Sponsor: Fudan University

Target Recruit Count: 93

Registration Number: NCT02662959

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

Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma

Phase 1

Completed

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Apatinib
Drug: Irinotecan

First Posted Date: 2016-01-05

Last Posted Date: 2021-03-18

Lead Sponsor: Peking University

Target Recruit Count: 12

Registration Number: NCT02645864

Locations: 🇨🇳
Peking University Cancer Hospital, Beijing, Beijing, China

A Study of BBI608 Administrated With FOLFIRI + Bevacizumab in Adult Patients With Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: BBI608
Drug: 5-FU
Drug: Irinotecan
Drug: Levofolinate
Drug: Bevacizumab

First Posted Date: 2015-12-30

Last Posted Date: 2022-04-12

Lead Sponsor: Sumitomo Pharma Co., Ltd.

Target Recruit Count: 4

Registration Number: NCT02641873

Locations: 🇯🇵
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
🇯🇵
National Cancer Center Hospital East, Kashiwa, Chiba, Japan

A Dose Escalation Study of MM-398 Plus Irinotecan in Patients With Unresectable Advanced Cancer

Phase 1

Completed

Conditions: Unresectable Advanced Cancer

Interventions: Drug: MM-398
Drug: Irinotecan
Drug: Leucovorin (LV)
Drug: 5-fluorouracile (5-FU)
Drug: bevacizumab

First Posted Date: 2015-12-28

Last Posted Date: 2017-01-31

Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

Target Recruit Count: 10

Registration Number: NCT02640365

Locations: 🇫🇷
Hôpital Saint Antoine, Paris, France

Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors

Phase 1

Active, not recruiting

Conditions: Malignant Solid Neoplasm

Interventions: Drug: Ferumoxytol
Drug: Irinotecan Sucrosofate
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Veliparib

First Posted Date: 2015-12-16

Last Posted Date: 2024-12-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 18

Registration Number: NCT02631733

Locations: 🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
NCI - Center for Cancer Research, Bethesda, Maryland, United States
🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

and more 3 locations

Avelumab in Third-Line Gastric Cancer (JAVELIN Gastric 300)

Phase 3

Completed

Conditions: Gastric Cancer Third Line
Unresectable, Recurrent, Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Interventions: Drug: Irinotecan
Drug: Avelumab
Other: Best Supportive Care (BSC)
Drug: Paclitaxel

First Posted Date: 2015-12-09

Last Posted Date: 2020-11-24

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

Target Recruit Count: 371

Registration Number: NCT02625623

Locations: 🇺🇸
Advanced Medical Specialties 8940 North Kendall Drive, Suite 300E, Miami, Florida, United States
🇺🇸
New York Oncology Hematology, P.C. 400 Patroon Creek Blvd, Suite 1, Albany, New York, United States
🇺🇸
Oncology Specialists, S.C. 1700 Luther Ln, Ste 2200, Park Ridge, IL 60068 7900 Milwaukee Ave, Ste 16, Niles, Illinois, United States

and more 72 locations

Trial in Metastatic Colorectal Cancer With FOLFIRI Plus Aflibercept as First Line Treatment

Phase 2

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: 5 Fluorouracil
Drug: Leucovorin
Drug: Irinotecan
Drug: Aflibercept

First Posted Date: 2015-12-08

Last Posted Date: 2019-02-22

Lead Sponsor: Hellenic Oncology Research Group

Target Recruit Count: 31

Registration Number: NCT02624726

Locations: 🇬🇷
Anticanscer Hospital of Athens "Agios Savvas", Athens, Greece
🇬🇷
University Hospital of Patras-Rio, Río, Greece
🇬🇷
General Hospital of Athens "Aretaieio", Athens, Greece

and more 7 locations

BATS With in Combination With Low Dose IL-1 and GM-CSF for Advanced Pancreatic Cancer

Phase 1

Completed

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

Interventions: Biological: Aldesleukin
Biological: Antibody Therapy
Drug: Fluorouracil
Drug: Gemcitabine Hydrochloride
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Oxaliplatin
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Biological: Sargramostim

First Posted Date: 2015-12-03

Last Posted Date: 2023-05-15

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Target Recruit Count: 2

Registration Number: NCT02620865

Locations: 🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

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