Product Description
Amgen is developing Ganitumab (AMG 479). It is a fully human anti-insulin-like growth factor receptor type I monoclonal antibody which inhibits the growth and survival of pancreatic carcinoma cells. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/19366899/)
Mechanisms of Action: IGF-1 Blocker
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Pancreatic Cancer|Adenocarcinoma|Sarcoma, Ewing|Bone Marrow Diseases|Peripheral Neuroectodermal Tumors, Primitive|Primitive Neuroectodermal Tumors|Bone Cancer|Endocrine Gland Cancer
Phase 2: Sarcoma|Carcinoid Tumor|Colorectal Cancer|Non-Small-Cell Lung Cancer|Islet Cell Adenoma|Neuroendocrine Tumors|Breast Cancer|Lymphoma|Pancreatic Cancer|Sarcoma, Ewing|Ovarian Cancer|Melanoma|Adenocarcinoma|Small Cell Lung Cancer|Alveolar Rhabdomyosarcoma|Embryonal Rhabdomyosarcoma|Peritoneal Cancer|Fallopian Tube Cancer|Squamous Cell Carcinoma|Gastrointestinal Cancer|Hemangiosarcoma|Small Cell Sarcoma|Triple Negative Breast Cancer|Primitive Neuroectodermal Tumors|Desmoplastic Small Round Cell Tumor
Phase 1: Sarcoma|Lymphoma, Non-Hodgkin|Colorectal Cancer|Oncology Solid Tumor Unspecified|Pancreatic Cancer|Non-Small-Cell Lung Cancer|Prostate Cancer|Intestinal Cancer|Ovarian Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| I-SPY | P2 |
Recruiting |
Hemangiosarcoma|Triple Negative Breast Cancer |
2030-12-01 |
2024-11-27 |
||
| NCI-2019-05820 | N/A |
Recruiting |
Sarcoma |
2025-12-31 |
2025-06-07 |
Primary Endpoints|Treatments |
|
| NCT04129151 | P2 |
Completed |
Sarcoma, Ewing |
2022-12-15 |
2024-07-18 |
Primary Endpoints|Treatments|Trial Status |
|
| 17-C-0049 | P2 |
Terminated |
Embryonal Rhabdomyosarcoma|Alveolar Rhabdomyosarcoma |
2021-09-15 |
2022-04-15 |
Primary Endpoints|Treatments|Trial Status |
|
| NCI-2014-02380 | P3 |
Active, not recruiting |
Peripheral Neuroectodermal Tumors, Primitive|Primitive Neuroectodermal Tumors|Sarcoma, Ewing|Bone Marrow Diseases |
2021-03-31 |
2024-11-27 |
Primary Endpoints|Treatments |
|
| AMG 479 | P2 |
Completed |
Colorectal Cancer|Carcinoid Tumor|Sarcoma|Non-Small-Cell Lung Cancer|Lymphoma |
2020-02-05 |
21% |
2021-02-22 |
Primary Endpoints|Treatments |
| 2006-7041-83/hah | N/A |
Not yet recruiting |
Pain, Postoperative|Acute Pain |
2019-04-15 |
|||
| RAP | P1 |
Completed |
Non-Small-Cell Lung Cancer |
2018-12-19 |
26% |
2019-08-30 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2012-001962-13 | P2 |
Completed |
Breast Cancer|Ovarian Cancer |
2017-06-01 |
2022-03-13 |
Treatments |
|
| NCT01024387 | P2 |
Completed |
Islet Cell Adenoma|Carcinoid Tumor|Neuroendocrine Tumors|Pancreatic Cancer |
2016-01-01 |
2019-03-22 |
Treatments |
|
| NCT01479179 | P2 |
Withdrawn |
Breast Cancer |
2015-11-01 |
2019-03-19 |
||
| CMEK162X2111 | P2 |
Terminated |
Melanoma|Adenocarcinoma|Pancreatic Cancer |
2015-04-01 |
2020-12-12 |
Primary Endpoints|Start Date |
|
| 1002-16; IUCRO-0287 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2015-01-19 |
2019-03-19 |
Treatments |
|
| CBYL719X2105J | P2 |
Terminated |
Breast Cancer|Ovarian Cancer |
2014-12-26 |
2019-03-19 |
||
| 2008-001551-22 | P2 |
Completed |
Ovarian Cancer |
2014-11-07 |
2022-03-12 |
Treatments |
|
| 2012-000305-76 | P2 |
Completed |
Melanoma|Pancreatic Cancer|Adenocarcinoma|Colorectal Cancer |
2014-10-27 |
2022-03-13 |
Treatments |
|
| GAMMA | P3 |
Terminated |
Adenocarcinoma|Pancreatic Cancer |
2014-08-15 |
2022-03-13 |
Treatments |
|
| 2007-006050-25 | P2 |
Terminated |
Breast Cancer |
2013-11-15 |
2025-06-08 |
Treatments |
|
| RTOG 1102 | P1 |
Completed |
Pancreatic Cancer |
2013-11-01 |
2019-03-19 |
||
| TRIO 014 | P2 |
Terminated |
Ovarian Cancer |
2013-09-01 |
2019-03-18 |
Treatments |
|
| 2008-004752-77 | P2 |
Completed |
Colorectal Cancer |
2013-07-30 |
2022-03-12 |
Treatments |
|
| JapicCTI-111468 | P3 |
Completed |
Pancreatic Cancer|Adenocarcinoma |
2013-06-20 |
|||
| 2008-001552-44 | P2 |
Completed |
Ovarian Cancer |
2013-05-23 |
2022-03-12 |
Treatments |
|
| TRIO 015 | P2 |
Completed |
Fallopian Tube Cancer|Peritoneal Cancer|Ovarian Cancer |
2013-05-01 |
2019-03-18 |
Treatments |
|
| 2008-003292-42 | P2 |
Completed |
Small Cell Lung Cancer |
2013-02-28 |
2022-03-12 |
Treatments |