TAX-TORC: A Phase I Multi-centre Trial of the Combination of AZD2014 (Dual mTORC1 and mTORC2 Inhibitor) and Weekly Paclitaxel in Patients With Solid Tumours

Trial ID # NCT02193633
Phase I
Drug Class Signaling Pathway Inhibitors: PI3K-AKT-mTOR/TORC1/2
Drug Name Vistusertib
Alternate Drug Names AZD2014
Drugs in Trial Paclitaxel, Vistusertib
Eligible Participant

Advanced solid tumors

Patients Enrolled

70 (Expansion: 25; median 3 prior therapies)

Therapy Setting


Study Design

Open-Label, Non-randomized


ORR, PFS, RP2D, evaluated per RECIST and CA125


RP2D: 80 mg/m2/week Pac and 50 mg bid 3/7days Vis; 6/7 weeks

Expansion cohort analysis (40% Pt-S/Part-Pt-S, 60% Pt-R/Pt-Rf):
ORR (RECIST): 52% (13PR, n=25)
ORR (CA125): 60%
PFS: 5.8 months

Clinically Significant Adverse Events

Dose Limiting Toxicities: fatigue, mucositis
Serious AE: none
Grade 3-4 AE: neutropenia (19%)


Promising drug combination with anti-tumor activity


Basu B et al. Vistusertib (dual m-TORC1/2 inhibitor) in combination with paclitaxel in patients with high grade serous ovarian and squamous non-small cell lung cancer. Ann Oncol (2018) 29(9):1918-1925

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