Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dalotuzumab/kg · 1 trial · 1 indication
To be declared a DLT an adverse experience had a causality related to study therapy. DLTs could be adverse experiences possibly, probably, or definitely related to study therapy by the Investigator, and included the following : Grade 4 neutropenia lasting \>= 5 days; Grade 3 or 4 neutropenia with fever \>38.5°C; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity, except inadequately treated diarrhea, nausea and vomiting, rash, hyperglycemia, and transient abnormality of electrolytes. Anemia, infusion reactions, hypersensitivity reactions, and adverse experiences not-related to study therapy did not qualify as DLTs.
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE.
| Arm | Type | Description |
|---|---|---|
| Cetux/Irin - Dmab 10 mg/kg | EXPERIMENTAL | After treatment with Cetuximab (Cetux) and Irinotecan (Irin), Dalotuzumab (Dmab) was administered as an intravenous infusion at 10 mg/kg in Cycle 1 on Days 22, 29 and 36; followed in subsequent cycles by treatment with 10 mg/kg on Days 1, 8, 15, 22, 29 and 36. Each cycle was 6 weeks long. |
| Cetux/Irin - Dmab 15/7.5 mg/kg | EXPERIMENTAL | After treatment with Cetux/Irin, Dmab was administered as an intravenous infusion at 15 mg/kg in Cycle 1 on Days 8, 22 and 36; followed in subsequent cycles by treatment with 7.5 mg/kg on Days 8, 22 and 36. Each cycle was 6 weeks long. |
| Dmab 10 mg/kg - Cetux/Irin (DDI) | EXPERIMENTAL | Dmab was administered in each cycle as an intravenous infusion at 10 mg/kg once weekly on Days 1, 22 and 29; followed by treatment with Cetux/Irin. For Drug-Drug Interaction (DDI). Each cycle was 6 weeks long. |
| Name | Type | Description |
|---|---|---|
| Dalotuzumab 10 mg/kg | BIOLOGICAL | Dalotuzumab at 10 mg/kg was intravenously administered once weekly |
| Cetuximab | BIOLOGICAL | Following pre-treatment with a histamine-receptor antagonist, Cetuximab was administered with an initial intravenous infusion of 400 mg/m\^2, followed by subsequent once weekly intravenous infusions of 250 mg/m\^2 |
| Irinotecan | DRUG | Irinotecan was administered with an intravenous infusion of 150 mg/m\^2, once every other week for 42 days |
| Dalotuzumab 15/7.5 mg/kg | BIOLOGICAL | Dalotuzumab was intravenously administered, with the first infusion of 15 mg/kg, followed by subsequent infusions of 7.5 mg/kg |
Inclusion Criteria: * Is 20 years of Age or older * Has a histologically or cytologically confirmed colorectal cancer * Has previously failed both Irinotecan and Oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective ...
Top 20 of 77 competitors
Dalotuzumab is an investigational oncology drug being studied for use in several cancer types, including advanced solid tumors, metastatic colorectal cancer, non-small-cell lung carcinoma, and other neoplasms. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Dalotuzumab is a monoclonal antibody that targets the insulin-like growth factor 1 receptor (IGF-1R). By binding to this receptor, it is designed to interfere with cancer cell growth and survival pathways. This mechanism is being evaluated in clinical trials for various solid tumors.
Dalotuzumab is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 2 clinical trials for oncology indications.
Dalotuzumab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. Clinical trials are ongoing to evaluate its safety and efficacy in treating various types of cancer.
Dalotuzumab has been studied in several clinical trials, including NCT00614393, a Phase 2 study in metastatic colorectal cancer combining it with cetuximab and irinotecan, which enrolled 558 participants. Other completed Phase 1 trials include NCT00701103 in advanced solid tumors and multiple myeloma, NCT00759785 in breast cancer, and NCT00925015 in colorectal cancer.
Yes, Dalotuzumab is also known as MK-0646. Clinical trial records refer to the drug by both names, such as in the study titles 'Study of Dalotuzumab (MK-0646) in Combination With Cetuximab and Irinotecan in Metastatic Colorectal Cancer (MK-0646-004)' and other trials.