Product Description
Irinotecan is a type of chemotherapy. It is also known by its brand name Campto. It is a treatment for cancer that started in the bowel (bowel cancer). This includes the colon and back passage (rectum). (Sourced from: https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/irinotecan)
Mechanisms of Action: TOP1 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: Fast Track - Pancreatic Cancer *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, France, Georgia, Germany, Hungary, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Adenocarcinoma|Colorectal Cancer|Esophageal Cancer|Gastrointestinal Cancer|Other|Pancreatic Cancer|Peritoneal Cancer|Small Cell Lung Cancer|Squamous Cell Carcinoma
Phase 2: Biliary Tract Cancer|Bladder Cancer|Brain Cancer|Brain Stem Cancer|Breast Cancer|Central Nervous System Cancer|Cholangiocarcinoma|Endometrial Cancer|Gastroenteropancreatic Neuroendocrine Tumor|Glioblastoma|Hepatoblastoma|Hepatocellular Carcinoma|Mesothelioma|Neuroblastoma|Neuroendocrine Carcinoma|Neuroendocrine Tumors|Neutropenia|Oncology Solid Tumor Unspecified|Osteosarcoma|Ovarian Cancer|Pancreatic Ductal Carcinoma|Peripheral Neuroectodermal Tumors, Primitive|Primary Central Nervous System Lymphoma|Primitive Neuroectodermal Tumors|Rhabdoid Tumor|Rhabdomyosarcoma|Sarcoma|Sarcoma, Ewing|Wilms Tumor
Phase 1: Appendiceal Cancer|Ataxia Telangiectasia|Bile Duct Cancer|Lyme Disease|Medulloblastoma|Melanoma|Prostate Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05694715 |
NCI-2023-00373 | P1 |
Recruiting |
Cholangiocarcinoma|Prostate Cancer|Colorectal Cancer|Gastrointestinal Cancer|Ataxia Telangiectasia|Lyme Disease|Ovarian Cancer|Breast Cancer|Melanoma |
2028-01-31 |
12% |
2024-11-27 |
Primary Endpoints|Treatments |
NCT04337177 |
VAL-10-001 | P1 |
Recruiting |
Rhabdomyosarcoma|Medulloblastoma|Sarcoma, Ewing|Hepatoblastoma|Neuroblastoma |
2026-06-01 |
12% |
2025-09-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05277766 |
PIPAC-NAL-IRI | P1 |
Recruiting |
Colorectal Cancer|Pancreatic Cancer|Gastrointestinal Cancer|Bile Duct Cancer|Peritoneal Cancer|Appendiceal Cancer |
2026-01-01 |
2025-07-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
|
NCT04920032 |
UCI 20-43 | P1 |
Recruiting |
Adenocarcinoma|Colorectal Cancer |
2025-12-31 |
12% |
2025-04-09 |
|
NCT06208657 |
OPTIMISE | P2 |
Recruiting |
Primary Central Nervous System Lymphoma|Brain Stem Cancer|Central Nervous System Cancer |
2030-12-01 |
12% |
2025-11-29 |
Primary Endpoints |
2024-515394-10-00 |
PM1183-A-014-15 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2026-01-01 |
2025-05-02 |
Treatments |
|
NCT04901702 |
ONITT | P2 |
Recruiting |
Wilms Tumor|Sarcoma, Ewing|Primitive Neuroectodermal Tumors|Osteosarcoma|Rhabdoid Tumor|Hepatoblastoma|Rhabdomyosarcoma|Neuroblastoma|Peripheral Neuroectodermal Tumors, Primitive |
2025-12-31 |
12% |
2025-12-03 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT04005339 |
NAPOLI-2 | P2 |
Recruiting |
Biliary Tract Cancer |
2025-12-30 |
12% |
2025-07-02 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT05022654 |
SI-B001_207 | P2 |
Active, not recruiting |
Esophageal Cancer|Squamous Cell Carcinoma |
2025-12-01 |
2% |
2025-09-27 |
Patient Enrollment|Primary Endpoints|Trial Status |
2024-514890-24-00 |
PM14-A-002-20 | P2 |
Active, not recruiting |
Neutropenia |
2025-11-30 |
2025-05-02 |
Treatments |
|
NCT05731518 |
SC0245-102 | P2 |
Recruiting |
Small Cell Lung Cancer |
2025-09-30 |
11% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT02611024 |
PM1183-A-014-15 | P2 |
Completed |
Endometrial Cancer|Neuroendocrine Tumors|Neuroendocrine Carcinoma|Small Cell Lung Cancer|Gastrointestinal Cancer|Ovarian Cancer|Gastroenteropancreatic Neuroendocrine Tumor|Adenocarcinoma|Mesothelioma|Colorectal Cancer|Sarcoma|Glioblastoma|Pancreatic Cancer |
2025-07-01 |
12% |
2025-07-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04469556 |
PASS-01 | P2 |
Active, not recruiting |
Pancreatic Cancer|Pancreatic Ductal Carcinoma|Adenocarcinoma |
2025-01-01 |
2024-11-27 |
Primary Endpoints|Treatments |
|
2019-000922-23 |
TACE with Irinotecan and Mitomycin C in HCC | P2 |
Completed |
Hepatocellular Carcinoma |
2023-11-22 |
2025-06-23 |
Treatments |
|
2016-002689-30 |
PHENOMENAL | P2 |
Active, not recruiting |
Breast Cancer|Brain Cancer |
2022-12-10 |
2022-03-13 |
Treatments |
|
2018-002936-26 |
TRITICC | P2 |
Active, not recruiting |
Bladder Cancer |
2022-09-28 |
2022-03-13 |
Treatments |
|
2011-004406-25 |
NEOFIRINOX | P3 |
Completed |
Other |
2023-07-01 |
2025-07-05 |
Treatments |
|
2023-509814-12-00 |
2023-509814-12-00 | P2 |
Recruiting |
Colorectal Cancer |
2031-03-31 |
2025-05-02 |
||
2020-003134-20 |
MEND-IT | P2 |
Active, not recruiting |
Colorectal Cancer |
2030-05-17 |
2022-03-13 |
Treatments |
|
jRCT2031210121 |
jRCT2031210121 | P2 |
Recruiting |
Sarcoma |
2029-01-14 |
|||
NCT06450041 |
NANT 2021-01 | P2 |
Recruiting |
Neuroblastoma |
2028-12-01 |
12% |
2025-11-05 |
Primary Endpoints|Treatments|Trial Status |
NCT07155200 |
SLICK Trial | P2 |
Not yet recruiting |
Small Cell Lung Cancer |
2028-07-31 |
2% |
2025-09-05 |
Primary Endpoints|Treatments |
2020-002141-42 |
PelvEx II | P3 |
Active, not recruiting |
Colorectal Cancer |
2028-07-03 |
2022-03-13 |
Treatments |
|
NCT07238283 |
HR070803-308 | P3 |
Recruiting |
Pancreatic Cancer |
2028-10-01 |
16% |
2025-12-11 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2022-501181-22-01 |
STEREOPAC-001 | P2 |
Recruiting |
Pancreatic Cancer|Adenocarcinoma |
2032-10-01 |
2025-05-02 |
Treatments |