Patients who received prior PIK, AKT or mTOR inhibitors are not allowed
Prior treatment with pazopanib or any phosphoinositide -kinase (PIK), mTOR, protein kinase B (AKT), or dual PIK/mTOR complex (CREB regulated transcription coactivator [TORC]/TORC) inhibitors will be prohibited
Patient must NOT have had previous treatment with any PIK or AKT inhibitor
Patients must not have any prior treatment with any PIK inhibitor, or lenalidomide
Prior treatment with a phosphatidylinositol (PI)-kinase, v-akt murine thymoma viral oncogene homolog (AKT) or mammalian target of rapamycin (mTOR) inhibitor in which the patient experienced a grade >= drug-related adverse event or otherwise would be at increased risk for additional PIK-related toxicity
Received prior treatment with a phosphoinositide--kinase (PIK) inhibitor
Prior treatment with idelalisib, other selective PIK? inhibitors, or a pan-PIK inhibitor.
Prior exposure to agents specifically targeting both mammalian target of rapamycin (mTOR) complexes (dual target of rapamycin complex [TORC] + target of rapamycin complex [TORC] inhibitors) and/or phosphoinositide -kinase (PIK)/ protein kinase B (AKT) pathways
AZD plus olaparib\r\n* Patients with solid tumors with PIKCA or AKT mutations or other molecular aberrations leading to dysregulation of the PIK/AKT pathway detected by NGS or RT-PCR in assays performed at a CLIA-certified laboratory:\r\n** activating mutations in PIKCA, AKT, AKT, AKT, ARIDA\r\n** other molecular aberrations leading to dysregulation of the PIK/AKT pathway, for example phosphoinositide--kinase regulatory subunit (PIKR)\r\n** during the course of the study new information may emerge relating to molecular aberrations that dysregulate the PIK/AKT pathway; patients whose tumors bear these aberrations can be included in the study
Previous therapy with GS- (CAL-), IPI- or any drug that specifically inhibits PIK or mechanistic target of rapamycin (mTOR) within last months
Prior treatment with everolimus, or any other specific or selective TORC/PIK/AKT inhibitor (eg, temsirolimus)
Patients should be excluded if they have had prior treatment with the combination of a PIK inhibitor and a PD- inhibitor
Prior treatment with approved or experimental therapeutic agents with known inhibition of the PIK pathway, including PIK inhibitors, AKT inhibitors, and mTOR inhibitors
Patients previously treated with hormonal therapy (tamoxifen, AI) or PIK, AKT, dual PIK/mTOR, TORC/, or mTORC inhibitors.
Prior treatment with PIK-inhibitor
Part B only: Participants must have squamous NSCLC; documented evidence of an activating molecular aberration of the PIK/mTOR pathway
Parts B, B, B & B: No previous treatment with any PIK and/or mTOR inhibitor
Intolerance to any previous treatment with any phosphatidylinositol--kinase (PIK) and/or mammalian target of rapamycin (mTOR) inhibitor.
Previous treatment with dual PIK/mTOR inhibitors, TORC/ inhibitors or TORC inhibitors.
Prior therapy with a PIK delta inhibitor
Prior treatment with a mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide -kinase (PIK) inhibitor.
Has received prior therapy with a PIK-inhibitor (prior therapy with a PIK-inhibitor is allowed if it was discontinued for intolerance)
Prior treatment with idelalisib, other selective PIK? inhibitors, or a pan PIK inhibitor.
Prior treatment with PIK/AKT inhibitors
Prior treatment with a selective PIK? inhibitor or a pan PIK inhibitor.
Previous treatment with phosphoinositide -kinase (PIK), serine/threonine-specific protein kinase (AKT), dual PIK/ mammalian (or mechanistic) target of rapamycin (mTOR) inhibitors, target of rapamycin complex / (TORC/) inhibitors or TORC inhibitors.
Prior treatment with an mTOR, AKT, or PIK inhibitor
Prior treatment with an mechanistic target of rapamycin (mTOR) inhibitor or phosphatidylinositol--Kinase (PIK) inhibitor is allowed but not required
Prior use of PIK or Akt inhibitors in the metastatic setting for the treatment of cancer; these include, but are not limited to: taselisib, GDC-, GDC-, BEZ, BKM, LY, PIK-, TGX-, XL, XL, SF, PX-, D-, D-, GSK, CAL; patients who have received PIK/Akt inhibitors previously for < weeks will be eligible
Documented evidence of resistance to prior treatment with idelalisib or other PIK inhibitors.
Patients who are receiving or may receive future treatment with PIK or TNFalpha inhibitors
Previous treatment with PIK inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
Patients who have received prior treatment with a PIK inhibitor or have known hypersensitivity to Gedatolisib or its excipients
Prior treatment with idelalisib (a PIK inhibitor).
Part E: Prior treatment with a PIK/mTOR inhibitor
Patient has any prior use of PIK inhibitors.
Patient has received prior treatment with any PIK inhibitors
Patients who have had prior therapy with any phosphatidylinositol kinase (PIK)/v-akt murine thymoma viral oncogene homolog (AKT)/mammalian target of rapamycin (mTor) pathway inhibitor
Prior therapy with a selective phosphoinositide -kinase (PIK) inhibitor or other B-cell receptor targeting agents is allowed
Patients who have received prior treatment with a pan-selective PIK inhibitor are not eligible
Subject has received previous treatment with a PIK inhibitor; exceptions may be made for subjects who discontinued treatment with a previous PIK inhibitor for reasons other than toxicity or progression and as long as it has been > months since discontinuation of the previous PIK inhibitor; this exception will require prior approval from the study PI at KUMC
Prior sensitivity or intolerance to PIK inhibitors
Patients who have had prior therapy with GSK or any other PIK/AKT/MTOR pathway inhibitor
Prior treatment with a PIK or protein kinase B (AKT) inhibitor; patients previously treated with an mechanistic target of rapamycin (mTOR) inhibitor are eligible
Patient has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, any PIK, mTOR or AKT inhibitor (pre-treatment with CDK/ inhibitors is allowed)
Previous therapy with GS- (CAL-, Idelalisib), IPI- (Duvelisib), TGR- or any drug that specifically inhibits PIK/ mTOR (including temsirolimus, everolimus), AKT or BTK Inhibitor (including Ibrutinib) in last months
Group A: Prior treatment with a selective phosphatidylinositol -kinase (PIK) ? inhibitor (eg, idelalisib), a pan-PIK inhibitor, or a BTK inhibitor (eg, ibrutinib).
Group B: Prior treatment with a selective PIK? inhibitor (eg, idelalisib) or a pan PIK inhibitor.
Prior therapy with obinutuzumab and/or chlorambucil or a PIK delta inhibitor
Prior treatment with a phosphatidylinositol -kinase (PIK) inhibitor, mammalian target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT) inhibitor
Group : Advanced solid tumors with PIK pathway alterations (PIKCA mutation or PTEN loss) after failure of at least one line of prior standard therapy or for whom no further standard therapy is indicated. Prior treatment may not include inhibitors of the PIK pathway.
Prior therapy with agents that target Phosphatidylinositide -kinases (PIK), Protein kinase B (AKT), or mechanistic target of rapamycin (mTOR). Participants with known hypersensitivity to everolimus or rapamycin derivatives are also excluded.
Prior treatment with PIK? or Bcl- inhibitors.
Previous therapy with Akt, PIK, and/or mTOR inhibitors
For Part D (abemaciclib + LY): Any subtype. The participant must have received at least two, but not more than three prior therapies for advanced/metastatic NSCLC. The participant must not have received prior treatment with any phosphoinositide -kinase (PIK) or mammalian target of rapamycin (mTOR) inhibitor.
Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or agent that inhibits the PIK-mTOR pathway
Patients previously treated with ibrutinib or PIK inhibitor
The patient has received prior treatment with a PIK inhibitor, AKT inhibitor, or mechanistic target of rapamycin (serine/threonine kinase) (mTOR) inhibitor (e.g. rapamycin, MK, perifosine, etc.)
Prior treatment with apalutamide or phosphatidylinositol- kinase (PIK)/mTOR pathway inhibitors
At least weeks must have elapsed from the use of any investigational agent prior to beginning protocol therapy\r\n* Note: prior treatment with phosphatidylinositol kinase (PIK)/mammalian target of rapamycin (mTOR) pathway inhibitors prohibited
Prior treatment with PIK/mTOR pathway inhibitors
At least one prior therapy; prior autologous or allogeneic stem cell transplant is allowed; patients may not be on chronic immunosuppressive therapy for graft-versus-host disease (GVHD); patients who have received prior treatment with a pan-selective PIK inhibitor are not eligible; however, prior therapy with a selective PIK inhibitor, Brutons tyrosine kinase inhibitor, or other B-cell receptor targeting agents is allowed
Patients with prior sensitivity or intolerance to PIK inhibitors are not eligible for participation
Patients must have NOT received any class of drugs targeted to the PIK pathway (such has PIK inhibitors or mechanistic target of rapamycin [mTOR] inhibitors) or RAS-ERK pathway for management of recurrent or persistent disease
Prior PIK inhibitor or AKT inhibitor (patients previously treated with everolimus are eligible)
Prior therapy with a PIK inhibitor; prior use of Akt or mammalian target of rapamycin (mTOR) inhibitors are allowed
Previous therapy with GS- (CAL-), IPI- or any drug that specifically inhibits the PIK or mTOR pathway;
Prior treatment with PIK inhibitors
Prior treatment with a PIK inhibitor
Prior treatment with idelalisib, other selective PIK? inhibitors, or a pan-PIK inhibitor.
History of prior therapy with any phosphatidylinositol -kinase (PIK) inhibitor (including idelalisib), or any anti-CD agent
Prior treatment with PIK inhibitor(s)
Previous treatment with a PIK or AKT inhibitor.
Progressive disease while previously receiving a PIK inhibitor (e.g. GS- [idelalisib], duvelisib) or a serious/severe AE related to PIK inhibitor treatment
Patient has received previous treatment with any AKT, mTOR inhibitors or PIK pathway inhibitors;
Received prior treatment with Insulin-like Growth Factor Receptor (IGF-R) inhibitors, Phosphatidylinositol -Kinase (PIK) inhibitors, or other experimental agents that target PIK, Protein Kinase B (AKT), or Mammalian Target of Rapamycin (mTOR) pathway
Prior treatment with PIK-inhibitors
AKT INHIBITOR MK ARM: Previous AKT inhibitor therapy
Patients previously treated with an mTOR, AKT, or PIK inhibitor (including but not limited to GDC-, GDC-, BEZ, BKM, LY, PIK-, TGX-, XL, XL, SF, PX-, D-, D-, GSK, CAL, everolimus, temsirolimus, and ridaforolimus); for agents not listed, the study principal investigator (PI) or Co-PI will make a determination
Patients previously treated with an mammalian TOR (mTOR) or PIK inhibitor
Patients must have known PIK/mTOR pathway gene aberrations (from molecular profiling studies).
Prior treatment with a phosphoinositide - kinase (PIK) inhibitor, Protein Kinase B Inhibitor is known as AKT inhibitor, or mammalian target of rapamycin (mTOR) inhibitor.
Part A: Intolerable AEs due to other PIK inhibitors, dual PIK and mTOR inhibitors or AKT inhibitors. Parts B, C, and D: Prior exposure to any of the following: pharmacological inhibitors of AKT, PIK, or dual PIK and mTOR kinase activity
The subject has previously been treated with a PIK inhibitor and taken off treatment due to treatment related AEs.
Patient has received previous treatment with PIK inhibitors, lomustine or carboplatin.
Prior treatment with phosphoinositide -kinase (PIK) inhibitor
Prior treatment with a PIK inhibitor
Patient has received previous treatment with PIK inhibitors
Prior treatment with an Akt inhibitor (prior PIK or mTOR inhibitors are allowed)
Previous treatment with PIK inhibitors, AKT inhibitors or fulvestrant
Have received a selective phosphoinositide--kinase alpha isoform (PIK-alpha) inhibitor
Prior treatment with fulvestrant, phosphoinositide -kinase (PIK) inhibitor, or mechanistic target of rapamycin (mTOR) inhibitor for ABC or MBC
History of significant toxicity related to another phosphatidylinositol -kinase (PIK) inhibitor or mammalian target of rapamycin (mTOR) inhibitor requiring treatment discontinuation
Prior treatment with PIK inhibitor
Prior treatment with a dual mTORC/mTORC inhibitor (CC- arms only) or BTK inhibitor (PCI-) (CC- arms only). [Prior treatment with rapamycin analogues, PIK or AKT inhibitors, lenalidomide and rituximab are allowed].
Participants who are receiving any other investigational agents; history of prior PIK, mTOR or CDK / inhibitor use for breast cancer
Prior therapy with mechanistic target of rapamycin (mTOR), phosphoinositide--kinase (PIK), or dual PIK-mTOR inhibitors, serine/threonine-specific protein kinase (AKT) inhibitors, or fulvestrant.