[c09aa8]: / clusters / 9knumclustersv2 / clust_1811.txt

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Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:\r\n* Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-, are eligible\r\n* Patients who have received prior therapy with ABI- are not eligible\r\n* Patients who have previously received irinotecan and temozolomide in combination without progressive disease while on therapy are eligible\r\n* Patients who have previously received irinotecan and temozolomide in combination and had significant toxicity with these two drugs are not eligible\r\n* Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible
Patients must not be receiving or planning to receive trastuzumab; concurrent bisphosphonate therapy is allowed; patients must not have prior exposure to mechanistic target of rapamycin (serine/threonine kinase) (mTOR) inhibitors (rapamycin, everolimus, temsirolimus, deforolimus); patients must not have prior treatment with any investigational drug within the preceding days and must not be planning to receive any other investigational drug for the duration of the study
Refractory disease to treatment with an mTOR inhibitor
Patient is INELIGIBLE if patient discontinued prior mTOR inhibitor due to toxicity
Patients who have previously received temsirolimus, another mTOR inhibitor, or any other investigational agent
Patients who are receiving any other anticancer or investigational or/and anti-neoplastic therapies, including chemotherapy, immunotherapy, target therapy, biological response modifiers\r\n* Previous treatment with CDK/ inhibitors (such as PD-, abemaciclib) and/or mTOR inhibitors (such as sirolimus, temsirolimus or everolimus)\r\n* Patients who are currently receiving treatment with agents that are known to cause corrected QT (QTc) prolongation or induce Torsades de Pointes\r\n* Known need for major surgery within days of the first dose of ribociclib and everolimus; please note: gastrostomy, insertion of a gastrostomy (G) tube, ventriculo-peritoneal shunt, endoscopic ventriculostomy and central venous access are NOT considered major surgery
Participants who have received previous treatment with a mammalian target of rapamycin (mTOR) inhibitor
Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
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 CDK/ inhibitors or mTOR inhibitors
Patients who have been previously treated with an mTOR inhibitor
Patients with hypersensitivity to mTOR inhibitors or tamoxifen.
Prior treatment with mTOR or TORC/ inhibitors (eg, rapamycin, temsirolimus, everolimus, deferolimus) is NOT allowed
Previous treatment with an mTOR inhibitor
Prior treatment with an mTOR inhibitor (including, but not limited to, everolimus, temsirolimus, sirolimus, and ridaforolimus)
Prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
Patients who have been previously treated with mTOR inhibitors such as everolimus and temsirolimus, or with c-MET inhibitors such as cabozantinib
Subjects may have received up to prior lines of systemic therapy (excluding any neoadjuvant/adjuvant therapy) including anti-VEGF or VEGFR inhibitor (e.g. sorafenib, pazopanib, sunitinib, bevacizumab, axitinib) or mTOR inhibitor (e.g. everolimus or temsirolimus) for metastatic disease
Patients previously exposed to, intolerant of, or ineligible for CDK inhibitors, mTOR inhibitors, and/or their combination
Patients can have had prior treatment for RCC including prior surgery, radiation therapy, immunotherapy with interleukin (IL)- or interferon (but not anti-programmed cell death [PD] or anti-cytotoxic T-lymphocyte-associated protein [CTLA-]), target therapy with receptor tyrosine kinase (RTK) inhibitors/mammalian target of rapamycin (mTOR) inhibitors, such as sunitinib, sorafenib, pazopanib, axitinib, everolimus, and temsirolimus (but not bevacizumab) or chemotherapy
Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
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 / inhibitors in combination with endocrine therapy for treatment of metastatic disease
DOSE ESCALATION COHORT: Subjects who have received sirolimus, everolimus, temsirolimus, or any other agent for current malignancy that theoretically targets PIK, AKT and / or mTOR
DOSE EXPANSION COHORT: Subjects who have received sirolimus, everolimus, temsirolimus, or any other agent for current malignancy that theoretically targets PIK, AKT and / or mTOR
Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors
Prior treatment with everolimus other than in combination with hormonal therapy for treatment of breast cancer or prior treatment with another mammalian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus) for any indication
For all stage participants, no prior treatment with mTOR, PI kinase or Akt inhibitors; prior treatment with mTOR, PI kinase or Akt inhibitors allowed in stage only
Patients MAY HAVE received non-cytotoxic (biologic or targeted) agent(s) as part of initial treatment and/or for management of recurrent or persistent disease, with the below stated exceptions (see NOTE below); prior hormonal therapy is allowed, but must be discontinued at least one week prior to registration\r\n* NOTE: Prior therapy with PIK inhibitors, AKT inhibitors and/or mammalian target of rapamycin (mTor) inhibitors (e.g., everolimus, temsirolimus) is NOT allowed; prior therapy with MEK inhibitors (e.g., AZD or selumetinib) is NOT allowed
Prior treatment with an mammalian target of rapamycin (MTOR) inhibitor (including everolimus, sirolimus, temsirolimus)
Prior treatment with mTOR inhibitor or other molecularly targeted therapy
Patients who have received prior treatment with a known mammalian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus)
Patients who have received prior treatment with an mammalian target of rapamycin (mTOR) inhibitor (e.g., sirolimus, temsirolimus, everolimus)
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
Part : Progression of disease following one VEGF pathway inhibitor for RCC (e.g. sunitinib, pazopanib, sorafenib, bevacizumab, tivozanib, or cabozantinib) inclusive of adjuvant therapy if there was documented disease progression during treatment. Patients may have received one additional line of an approved mTOR kinase inhibitor (e.g. everolimus, temsirolimus). Prior exposure to investigational and/or approved anticancer immune therapies is permitted.
Prior treatment with mTOR inhibitors (everolimus or temsirolimus) or CB-
Previous treatment with exemestane or mTOR inhibitors* (Note: Patients with disease refractory to prior LEE are excluded for dose expansion Group only).
Patients who have previously received everolimus, any another mTOR inhibitor or any agent targeting the PIK/AKT/mTOR pathway.
Prior mTOR inhibitors for the treatment of cancer.
Patients who have prior therapy with everolimus or any other mammalian target of rapamycin (mTOR) inhibitor
Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus).
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 (C)/ inhibitors (but not mTORC inhibitors such as everolimus or other rapalogues)
Prior mTOR inhibitor therapy within weeks prior to first dose of study drug.
Patients must not have prior exposure to mammalian target of rapamycin (mTOR) inhibitors (e.g. rapamycin, everolimus, sirolimus, temsirolimus, deforolimus)
Prior failed treatment with mTOR inhibitors
Prior therapy with mTOR inhibitors, including sirolimus, temsirolimus, deforolimus within months prior to enrollment
Patients who have received prior treatment with a mammalian target of rapamycin (mTOR) inhibitor (e.g., sirolimus, temsirolimus, everolimus)
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 weeks prior to randomization in the study.
Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
Prior therapy with mammalian target of rapamycin (mTOR) inhibitors (e.g. sirolimus, temsirolimus)
Patients who have received prior systemic therapy for their RCC with vascular endothelial growth factor (VEGF) pathway inhibitor (such as sunitinib, sorafenib, and bevacizumab) or with mammalian target of rapamycin (mTOR) inhibitors (such as sirolimus, temsirolimus, everolimus, or deforolimus)
Part B only: Prior treatment with agents targeting both mammalian target of rapamycin (mTOR) complexes (dual mammalian target of rapamycin complex / inhibitors) and/or PIK/AKT pathways. However, prior treatment with isolated target of rapamycin complex (TORC) inhibitors (eg., rapalogs) is allowed in both parts of this study.
No prior mTOR inhibitors
Patients who have received prior treatment with an mTOR inhibitor (e.g., sirolimus, temsirolimus, everolimus); patients who have received prior treatment with Navelbine within prior months
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
Had any prior treatment with temsirolimus or mTOR inhibitor.
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
Patients who have received prior treatment with an mTOR inhibitor (e.g. sirolimus, temsirolimus, everolimus)
Prior treatment with trastuzumab or other HER-directed therapies or with a mammalian target of rapamycin (mTOR) inhibitor within months of study entry (when cancer was not definitely hormone refractory)
Patients who have received prior treatment with an mTOR inhibitor (sirolimus, temsirolimus, everolimus)
Patients who have received prior treatment with an mammalian target of rapamycin (mTOR) inhibitor (e.g., sirolimus, temsirolimus, everolimus)
History of significant toxicity related to mTOR inhibitor requiring treatment discontinuation
Prior exposure to lenvatinib or mammalian target of rapamycin (mTOR) inhibitor
Prior treatment with everolimus or another mammalian target of rapamycin (mTOR) inhibitor (temsirolimus)
Patients may not have had prior treatment with mTOR, peptidase inhibitor , skin-derived (PI) 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 toxicity attributed to the mTOR inhibitor with prior therapy
Prior treatment with an mTOR inhibitor (including sirolimus) is allowed; however, patients with >= grade toxicities with an mTOR inhibitor are excluded
Subjects with prior treatment with a mechanistic target of rapamycin (mTOR) are eligible