Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)

Korábbi kezelés

• Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR pathways:
  • This includes (but is not limited to):
  • mTOR inhibitors: temsirolimus, everolimus, ridaforolimus, sirolimus, salirasib, CC-223, INK128, DS-3078, CC-115, AZD-2014
  • Dual PI3K/mTOR inhibitors: BEZ235, XL-765, GDC 0980, PF-04691502, GSK 2126458, Quinacrine, PKI-587, P-P7170, LY3023414, GDC 0084, DS 7423, CBLC-137
  • Pan-PI3K inhibitors: BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), BAY-806946, ZSTK-474, WX 037, SRX5000, SRX2523, AMG511, PQR308, BAY 94-9343
  • PI3K inhibitors with beta isoform activity: prior GSK2636771 is not allowed, nor is GS-9820, PQR3XX, KAR4139
  • The following treatments are allowed:
  • BYL719 (PI3Kalpha inhibitor)
  • GDC-0032 (PI3Kalpha inhibitor)
  • INK1117 (PI3Kalpha inhibitor)
  • Idelalisib (PI3Kdelta inhibitor)
  • IPI-125 (PI3K gamma delta inhibitor)
  • TGR1202 (PI3Kdelta inhibitor)
  • SRX2558 (PI3Kdelta inhibitor)
  • RP6530 (PI3K gamma delta inhibitor)
  • PWT143 (PI3Kdelta inhibitor)
  • IPI443 (PI3K gamma delta inhibitor)
  • GNE293 (PI3Kdelta inhibitor)

Más betegség

• Patients must not have known hypersensitivity to GSK2636771 or compounds of similar chemical or biologic composition.
• Patients with a history of interstitial lung disease or pneumonitis are excluded

Laborértékek

• Patients must not have any congenital platelet function defects and cannot be on any of the following anti-platelet drugs: clopidogrel, ticlopidine, prasugrel, that act at platelet purinergic receptors
  • Any need for starting anti-platelet therapy in a patient enrolled to this arm will have to be evaluated by the subprotocol chair

Egyéb

• Patients must not have tumors harboring co-existing aberrations activating the PI3K/MTOR and MAPK pathways, such as PIK3CA, PIK3R1, BRAF, KRAS and AKT1, TSC1/2, mTOR, NF2, NRAS, HRAS, NF1

• Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
• Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
• Patients must have PTEN gene mutation/deletion
  • There must be evidence of PTEN expression by immunohistochemistry (IHC) (any amount of staining will be considered positive for expression)
  • Patients with complete loss of PTEN by IHC, regardless of PTEN mutations/deletion status, will be enrolled into MATCH subprotocol EAY131-P, not this subprotocol (EAY131-N)
• Patients must have hemoglobin \>= 9 g/dL
• Patients must have a serum creatinine that =\< 1.5 x upper limit of normal (ULN) or have a 24-hour creatinine clearance of \>= 50 mL/min