Refractory disease to treatment with an mTOR inhibitor
Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity
Participants who have received previous treatment with a mammalian target of rapamycin (mTOR) inhibitor
Participants may have received any number of prior therapies, from 0 to > 10; prior treatment with phosphatidylinositol 3 (PI3)-kinase or mTOR inhibitors is not permitted, unless they were given as adjuvant therapy without undue toxicity, and without suggestion of resistance to therapy
Patients may have received prior chemotherapy (excluding prior mTOR inhibitors)
Patients may NOT have received prior mTor inhibitors
Patients who have received prior treatment with an mTOR inhibitor
Previous treatment with CDK4/6 inhibitors or mTOR inhibitors
Patients who have been previously treated with an mTOR inhibitor
Patients with hypersensitivity to mTOR inhibitors or tamoxifen.
Previous treatment with an mTOR inhibitor
Patients previously exposed to, intolerant of, or ineligible for CDK inhibitors, mTOR inhibitors, and/or their combination
Patients who have received a prior mammalian target of rapamycin (mTOR) inhibitor
Patients who have received prior treatment with an mTOR inhibitor
Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors
For all stage 2 participants, no prior treatment with mTOR, PI3 kinase or Akt inhibitors; prior treatment with mTOR, PI3 kinase or Akt inhibitors allowed in stage 1 only
Prior treatment with mTOR inhibitor or other molecularly targeted therapy
No prior systemic chemotherapy for metastatic disease; one prior therapeutic regimen with a non-tyrosine kinase inhibitor, such as an mammalian target of rapamycin (mtor) inhibitor is allowed; patients who were randomized to placebo on an adjuvant study are eligible
Use of mammalian target of rapamycin (mTOR) inhibitors prior to transplant and as post-transplant immunosuppression
Concomitant oral mTOR inhibitor treatment
No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)
Previous treatment with exemestane or mTOR inhibitors* (Note: Patients with disease refractory to prior LEE011 are excluded for dose expansion Group 3 only).
Patients who have previously received everolimus, any another mTOR inhibitor or any agent targeting the PI3K/AKT/mTOR pathway.
Prior mTOR inhibitors for the treatment of cancer.
Pre-treatment with other mTOR inhibitors may be allowed and should be discussed with the medical monitor
Previous meningioma progression during treatment with other mTOR complex 1 (C1)/2 inhibitors (but not mTORC1 inhibitors such as everolimus or other rapalogues)
Prior mTOR inhibitor therapy within 4 weeks prior to first dose of study drug.
Prior failed treatment with mTOR inhibitors
Prior treatment with everolimus, other mammalian target of rapamycin (mTOR) inhibitors, or anti-VEGF drug (sunitinib, bevacizumab)
Previous treatment with mTOR inhibitors.
Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
Patients who have received prior treatment with an mTOR inhibitor or bevacizumab
Interferons, Everolimus (mTOR-inhibitors) or other systemic therapies within 4 weeks prior to randomization in the study.
Part B only: Prior treatment with agents targeting both mammalian target of rapamycin (mTOR) complexes (dual mammalian target of rapamycin complex 1/2 inhibitors) and/or PI3K/AKT pathways. However, prior treatment with isolated target of rapamycin complex 1 (TORC1) inhibitors (eg., rapalogs) is allowed in both parts of this study.
No prior mTOR inhibitors
Prior everolimus or pazopanib therapy; other mammalian target of rapamycin (mTOR) inhibitors and tyrosine kinase inhibitors are allowed
EXPANSION COHORT ONLY: Prior mTOR pathway inhibitors or VEGF receptor inhibitor therapy
No prior therapy with an mTOR-pathway inhibitor
Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors
Previous treatment with mTOR inhibitors, or exemestane for advanced disease.
Parts A and B only: Has received mTOR inhibitor(s) as their only prior treatment for ccRCC.
Prior use of histone deacetylases (HDAC) or mammalian target of rapamycin (mTOR) inhibitors
Prior treatment with an mTOR inhibitor.
Prior treatment with pan-histone deacetylases (HDAC) or mammalian target of rapamycin (mTOR) inhibitor
Prior treatment with trastuzumab or other HER2-directed therapies or with a mammalian target of rapamycin (mTOR) inhibitor within 12 months of study entry (when cancer was not definitely hormone refractory)
History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation
Prior exposure to lenvatinib or mammalian target of rapamycin (mTOR) inhibitor
Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids, tumor necrosis factor (TNF) alpha antagonists, antibodies to interleukin (IL) 6 or IL6 receptor (R), calcineurin inhibitors, mammalian target of rapamycin (mTOR) antagonists
Patients may not have had prior treatment with mTOR, peptidase inhibitor 3, skin-derived (PI3) kinase or Akt inhibitors
Pre-treatment with other mTOR inhibitors may be allowed and should be discussed with the medical monitor
Prior treatment with mammalian target of rapamycin (mTOR) inhibitors will be allowed as long as the patient did not have >= grade 3 toxicity attributed to the mTOR inhibitor with prior therapy
Prior treatment with an mTOR inhibitor (including sirolimus) is allowed; however, patients with >= grade 3 toxicities with an mTOR inhibitor are excluded
Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible
Non-clear cell histology: 0-3 prior systemic therapies and may include mTOR inhibitor