a study of loxo-783 in patients with breast cancer/other solid tumors

Conditions: Breast Cancer

Summary: the main purpose of this study is to learn more about the safety, side effects, and effectiveness of loxo-783. loxo-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the pik3ca gene). participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.


Eligibility criteria:
inclusion criteria: * have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (pik3ca) h1047r mutation (or other sponsor and safety review committee (src)-approved, activating pik3ca mutations other than h1047r mutation) * have adequate archival tumor tissue sample available or be approved by the sponsor for enrollment if no tumor sample is available. * have stopped all cancer treatment and have recovered from the major side effects * have adequate organ function, as measured by blood tests * have a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) scale * patients must have * measurable disease --- patients with non-breast tumor types must have at least 1 measurable lesion * non-measurable bone disease (at least 1 bone lesion in breast cancer patients only) * for patients with an estrogen receptor (er)+ breast cancer diagnosis: * if female, must be postmenopausal * if male, must agree to use hormone suppression * phase 1a: -- dose escalation and backfill patients: * advanced solid tumor * patients may have had up to 5 prior regimens for advanced disease * phase 1b: * part a: * er+/human epidermal growth factor receptor 2 (her2)- advanced breast cancer * patients may have had up to 5 prior regimens for advanced disease ---- prior cyclin dependent kinase (cdk)4/6 inhibitor therapy required * part b: * er+/her2- advanced breast cancer * patients may have had up to 2 prior regimens for advanced disease. * part c: * er+/her2- advanced breast cancer * patients may have had up to 5 prior regimens for advanced disease. ---- prior cdk4/6 inhibitor therapy required. * have a diagnosis of diabetes mellitus type 2 * part d: * advanced breast cancer * patients may have had up to 5 prior regimens for advanced disease. * part e: * advanced solid tumor * patients may have had up to 3 prior regimens for advanced disease advanced disease * part f: * er+/her2- advanced breast cancer * patients may have had up to 5 prior regimens for advanced disease * prior cyclin dependent kinase (cdk)4/6 inhibitor therapy required exclusion criteria: * medical conditions * colorectal cancer * endometrial cancers with specific concurrent oncogenic alterations * a history of known active or suspected * diabetes mellitus type 1 or * diabetes mellitus type 2 requiring antidiabetic medication (phase 1a and all parts of phase 1b except part c). * serious concomitant systemic disorder * known or suspected history of untreated or uncontrolled central nervous system (cns) involvement. * active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process * prior exposure to phosphatidylinositol 3-kinase/protein kinase b/mammalian target of rapamycin (pi3k/akt/mtor) inhibitor(s), except in certain circumstances