Phase
Condition
Cancer
Bone Neoplasm
Multiple Myeloma
Treatment
Taselisib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have met applicable eligibility criteria in the Master MATCH Protocolprior to registration to treatment subprotocol
Patients must have a PIK3CA mutation as determined via the MATCH Master Protocol
Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatmentassignment and must have no clinically important abnormalities in rhythm, conductionor morphology of resting ECG (e.g. complete left bundle branch block, third degreeheart block)
Patients with known left ventricular dysfunction must have echocardiogram (ECHO) ormultigated acquisition scan (MUGA) within 4 weeks prior to registration to treatmentand must not have left ventricular ejection fraction (LVEF) < institutional lowerlimit of normal (LLN). If the LLN is not defined at a site, the LVEF must be > 50%for the patient to be eligible
Patients must have a fasting glucose =< 125 mg/dL
NOTE: Please provide clear documentation that the glucose test was conducted ata fasting state
Patients with prior treatment with an mTOR inhibitor are acceptable. These include,but are not limited to: temsirolimus, everolimus, ridaforolimus, sirolimus, CC-223,MLN128 (INK128), DS-3078, CC-115, AZD-2014, AZD8055
Exclusion
Exclusion Criteria:
Patients must not have known hypersensitivity to GDC-0032 (taselisib) or compoundsof similar chemical or biologic composition
Patients must not have breast cancer
Patients with squamous cell carcinoma of the lung who have PIK3CA mutations who haveaccess to AND are eligible for Lung-MAP (S1400) are not eligible
Patients must not have KRAS mutations, and/or PTEN mutation or loss, detected in thetumor sample as determined by the MATCH screening assessment. PTEN loss will bedetermined by immunohistochemistry
Patients must not have had prior therapy with a PI3K inhibitor or PI3K/mTORinhibitor. These include, but are not limited to: BEZ235, XL-765 (SAR245409),GDC-0980, PF-04691502, PF-05212384 (PKI-587), SF-1126, GSK 2126458, P-7170, BGT-226,LY3023414, GDC-0084, DS-7423, BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), VS-5584, BAY-80-6946, ZSTK-474, WX 037, AZD8835, GSK2636771, GS-9820,BYL719, MLN1117 (INK1117), idelalisib, TGR1202, RP6530, duvelisib (IPI-145),CUDC-907. Prior GDC-0032 (taselisib) is not allowed
Patients must not have had prior therapy with an Akt inhibitor. These include, butare not limited to: MK-2206, GSK690693, AZD5363, triciribine, perifosine,GSK2141795, GSK2110183, SR13668, BAY1125976, GDC-0068 (ipatasertib), LY2780301,ARQ092
Patients must not have type 1 or 2 diabetes requiring anti-hyperglycemic medication (e.g. metformin, glipizide, insulin)
Patients must not have current dyspnea at rest or require any daily supplementaloxygen
Patients must not have history of inflammatory bowel disease (e.g. Crohn's diseaseor ulcerative colitis) or active bowel inflammation (e.g. diverticulitis)
Study Design
Study Description
Connect with a study center
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania 19103
United StatesSite Not Available
ECOG-ACRIN Cancer Research Group
Philadelphia 4560349, Pennsylvania 6254927 19103
United StatesSite Not Available

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