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 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
_