Combination anti-cancer therapy

A method for the treatment of cancer, comprising administering to a subject in need of such treatment an amount of an anti-cancer agent or treatment that elevates pAkt levels in tumor cells;

• and an amount of an IGF-1R kinase inhibitor of Formula (I);
• wherein at least one of the amounts is administered as a sub-therapeutic amount.

A method for treating tumors or tumor metastases in a patient, comprising administering to said patient simultaneously or sequentially a synergistically effective therapeutic amount of a combination of an anti-cancer agent or treatment that elevates pAkt levels in tumor cells and an IGF-1R kinase inhibitor of Formula (I).

A method for treating tumors or tumor metastases in a patient refractory to treatment with an anti-cancer agent or treatment that elevates pAkt levels in tumor cells as a single agent, comprising administering to said patient simultaneously or sequentially a therapeutically effective amount of a combination of said anti-cancer agent or treatment and an IGF-1R kinase inhibitor of Formula (I).

A pharmaceutical composition comprising an anti-cancer agent that elevates pAkt levels in tumor cells and an IGF-1R kinase inhibitor of Formula (I), in a pharmaceutically acceptable carrier.

A kit comprising a container, comprising an IGF-1R kinase inhibitor of Formula (I), and an anti-cancer agent that elevates pAkt levels in tumor cells.

A method of identifying tumor cells that will respond most favorably to treatment with a combination of an anti-cancer agent or treatment that elevates pAkt levels in tumor cells and an IGF-1R kinase inhibitor, comprising:

• contacting a sample of tumor cells with said anti-cancer agent or treatment that elevates pAkt levels in tumor cells,
• determining whether said anti-cancer agent or treatment stimulates phosphorylation of IGF-1R or IR in the tumor cells, by comparing the level of p-IGF-1R or p-IR in tumor cells contacted with said anti-cancer agent or treatment to the level of p-IGF-1R or p-IR in an identical sample of tumor cells either not contacted with said anti-cancer agent or treatment, or contacted with a lower concentration of said anti-cancer agent or treatment, and predicting whether the sample tumor cells will respond favorably to treatment with a combination of an anti-cancer agent or treatment that elevates pAkt levels in tumor cells and an IGF-1R kinase inhibitor, wherein the higher the level of p-IGF-1R or p-IR induced by said anti-cancer agent or treatment in tumor cells, the greater likelihood that the tumor cells will respond favorably to treatment with a combination of an anti-cancer agent or treatment that elevates pAkt levels in tumor cells and an IGF-1R kinase inhibitor.