Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMC-A12-kg · 1 trial · 1 indication
PFS is defined as the time from date of first dose of study drug until the date of objective PD or death due to any cause, whichever occurs first. PD defined as a ≥20% increase in the sum of the longest diameter (LD) of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants who died without PD were considered to have progressed on the date of death. Participants who were alive and without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and are subsequently lost to follow-up were censored at the date of their last objective tumor assessment before loss to follow-up. Participants who progressed or died after ≥2 missed tumor assessment visits were censored at the date of their last objective tumor assessment before missed assessments. Participants who begin a new anticancer therapy were censored at the date of their last objective tumor assessment before initiation of new therapy.
| Arm | Type | Description |
|---|---|---|
| Cohort 1, IMC A12 - 10 mg/kg | ACTIVE_COMPARATOR | Treatment cycles will repeat until there is evidence of progressive disease (PD), toxicity, or withdrawal. If any participant experiences a dose-limiting toxicity (DLT), an additional 3 participants will be enrolled at this dose level (for a total of 6). If no further DLTs, enrollment into Cohort 2 will occur. |
| Cohort 2, IMC A12 20 - mg/kg | ACTIVE_COMPARATOR | Treatment cycles will repeat until there is evidence of PD, toxicity, or withdrawal. |
| Name | Type | Description |
|---|---|---|
| IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg) | BIOLOGICAL | intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle |
| IMC-A12 (cixutumumab) - 20 mg/kg | BIOLOGICAL | intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle |
| Sorafenib | DRUG | 400 milligrams (mg) twice per day orally |
Inclusion Criteria: * The participant has histologically or cytologically confirmed, unresectable HCC * The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiat...
IMC-A12 is an investigational oncology drug being studied for advanced solid tumors, Ewing's Sarcoma/Peripheral Neuroectodermal Tumor (PNET), head and neck cancer, non-small cell lung cancer, colorectal cancer, and adenocarcinoma of the prostate. It is a small molecule in Phase 2 clinical development.
IMC-A12 is being developed by Eli Lilly and Company (NYSE: LLY). The drug is an investigational small molecule in Phase 2 clinical development for multiple oncology indications, including advanced solid tumors and Ewing's Sarcoma/Peripheral Neuroectodermal Tumor (PNET).
IMC-A12 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for indications including adenocarcinoma of the prostate and advanced sarcoma, but the drug remains investigational.
IMC-A12 has completed several clinical trials. NCT00520481 studied it in metastatic prostate cancer with 41 participants. NCT00668148 studied it in advanced sarcoma with 113 participants. NCT00785538 and NCT00785941 studied it in advanced solid tumors with 24 and 16 participants respectively.
Yes, IMC-A12 is also known as cixutumumab. Clinical trial NCT00520481, titled 'Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer,' confirms that IMC-A12 and cixutumumab refer to the same drug.