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MOLECULARLY TARGETED: PTEN loss/LOF: myTACTIC Arm D(1)

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

Title
Genentech ML42439 (myTACTIC) PTEN
Study Title

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors

Site Link
Malignancy
Any: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
Any line
Investigational Agent
Ipatasertib
Drug Class
AKT inhibitor
PI
Axel Grothey, MD
Sponsor
Genentech, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
  • Positive biomarker results from a CLIA certified lab, either tissue or blood sample
  • Either PTEN protein loss as determined by a CLIA or equivalently certified immunohistochemistry assay OR
  • PTEN loss of function defined as PTEN dominant negative missense mutations or deleterious in-frame and missense mutations affecting protein function
  • ECOG PS 0-2
  • No symptomatic CNS metastases
  • No known HIV/HBV/HCV
  • No other malignancy within 3 years of study
  • No prior treatment with crizotinib
  • No insuline dependent diabetes
Objective
  • Primary-
    • ORR
  • Secondary
    • PFS
    • DoR
    • OS
    • PFS at various time points
    • DCR
    • Safety
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
PTEN loss or loss of function
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X