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: Eastern America
Company Founding Year: 1849
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: 6
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|Oncology 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 |
|---|---|---|---|---|---|---|---|---|
NCT02813135 |
ESMART | P2 |
Recruiting |
Oncology Unspecified |
2031-02-01 |
2026-01-17 |
||
NCT06208657 |
OPTIMISE | P2 |
Recruiting |
Brain Stem Cancer|Primary Central Nervous System Lymphoma|Central Nervous System Cancer |
2030-12-01 |
12% |
2025-11-29 |
Primary Endpoints |
NCT07356973 |
OPTICAL | P2 |
Not yet recruiting |
Glioblastoma |
2029-05-01 |
12% |
2026-01-27 |
Primary Endpoints |
jRCT2031210121 |
jRCT2031210121 | P2 |
Recruiting |
Sarcoma |
2029-01-14 |
|||
NCT05694715 |
NCI-2023-00373 | P1 |
Recruiting |
Breast Cancer|Cholangiocarcinoma|Melanoma|Ovarian Cancer|Prostate Cancer|Lyme Disease|Colorectal Cancer|Gastrointestinal Cancer|Ataxia Telangiectasia |
2028-01-31 |
12% |
2024-11-27 |
Primary Endpoints|Treatments |
NCT04337177 |
VAL-10-001 | P1 |
Recruiting |
Rhabdomyosarcoma|Medulloblastoma|Neuroblastoma|Hepatoblastoma|Sarcoma, Ewing |
2026-06-01 |
12% |
2025-09-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05153239 |
LAGOON | P3 |
Active, not recruiting |
Small Cell Lung Cancer |
2026-04-01 |
33% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT07364422 |
JPI-547-103 | P2 |
Not yet recruiting |
Gastrointestinal Cancer |
2026-02-28 |
12% |
2026-01-24 |
Primary Endpoints |
NCT05733689 |
RANT-GC Trial | P1 |
Recruiting |
Adenocarcinoma|Gastrointestinal Cancer|Esophageal Cancer |
2026-02-01 |
50% |
2025-07-09 |
|
NCT06512428 |
HA1818-004 | P2 |
Recruiting |
Squamous Cell Carcinoma|Esophageal Cancer |
2026-01-30 |
38% |
2024-11-27 |
|
NCT06172036 |
CAPT-02 | P2 |
Not yet recruiting |
Pancreatic Cancer |
2026-01-20 |
2025-08-27 |
||
NCT05277766 |
PIPAC-NAL-IRI | P1 |
Recruiting |
Pancreatic Cancer|Colorectal Cancer|Peritoneal Cancer|Bile Duct Cancer|Appendiceal Cancer|Gastrointestinal Cancer |
2026-01-01 |
2025-07-02 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
|
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 |
Primitive Neuroectodermal Tumors|Peripheral Neuroectodermal Tumors, Primitive|Sarcoma, Ewing|Osteosarcoma|Wilms Tumor|Rhabdoid Tumor|Hepatoblastoma|Rhabdomyosarcoma|Neuroblastoma |
2025-12-31 |
12% |
2025-12-03 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
2024-514890-24-00 |
PM14-A-002-20 | P2 |
Active, not recruiting |
Neutropenia |
2025-11-30 |
2025-05-02 |
Treatments |
|
NCT04005339 |
NAPOLI-2 | P2 |
Active, not recruiting |
Biliary Tract Cancer|Gastrointestinal Cancer |
2025-09-03 |
12% |
2026-01-27 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT02611024 |
PM1183-A-014-15 | P2 |
Completed |
Gastroenteropancreatic Neuroendocrine Tumor|Endometrial Cancer|Small Cell Lung Cancer|Neuroendocrine Carcinoma|Glioblastoma|Ovarian Cancer|Mesothelioma|Pancreatic Cancer|Adenocarcinoma|Colorectal Cancer|Sarcoma|Gastrointestinal Cancer|Neuroendocrine Tumors |
2025-07-01 |
12% |
2025-07-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT04469556 |
PASS-01 | P2 |
Completed |
Pancreatic Cancer|Adenocarcinoma|Pancreatic Ductal Carcinoma |
2025-03-05 |
2026-02-21 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
|
2019-000922-23 |
TACE with Irinotecan and Mitomycin C in HCC | P2 |
Completed |
Hepatocellular Carcinoma |
2023-11-22 |
2025-06-23 |
Treatments |
|
2011-004406-25 |
NEOFIRINOX | P3 |
Completed |
Other |
2023-07-01 |
2025-07-05 |
Treatments |
|
2016-002689-30 |
PHENOMENAL | P2 |
Active, not recruiting |
Brain Cancer|Breast 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 |
|
2022-501181-22-01 |
STEREOPAC-001 | P2 |
Recruiting |
Pancreatic Cancer|Adenocarcinoma |
2032-10-01 |
2025-05-02 |
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 |