Agnostos Trial is a multicentric phase 2 randomized trial with a 'pick-the-winner design' in chemonaive patients with cancer of unknown primary. It will assess the efficacy of the two best active single agent - carboplatin or gemcitabine - added to an innovative taxane back bone (nab-Paclitaxel). Agnostos trial is a part of a larger clinical and translational initiative to improve the outlook of patients with cancer of unknown primary through evaluation of novel chemotherapeutic regimens.
Treatment-naïve patients with CUP diagnosis confirmed according to CUP Diagnostic Guidelines, will be enrolled into AGNOSTOS trial. Patients will be randomized upfront to receive a nab-paclitaxel-based duplet adding either carboplatin or gemcitabine until progression or unacceptable toxicity (randomization 1:1, n= 120; 60 per arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Investigative Clinical Oncology (Oncologia Medica 2)
Candiolo, Turin, Italy
AOU Policlinoco S Orsola - Malpighi
Bologna, Italy
Ospedali Galliera
Genova, Italy
Istituto Europeo di Oncologia - IEO
Milan, Italy
Objective response rate (ORR) as evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines.
Time frame: 42 months
duration of response according to RECIST version 1.1.
Time frame: 42 months
time to progression
Time frame: 42 months
overall survival
Time frame: 42 months
toxicity according to Common Terminology Criteria for Adverse Events - CTCAE version 4.03.
Time frame: 42 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Istituto Nazionale dei Tumori
Milan, Italy
Ospedale Niguarda Cà Granda
Milan, Italy
Istituto Oncologico Veneto - IOV
Padova, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Policlinico Universitario Campus Biomedico
Roma, Italy
A.O.U S.Giovanni Battista
Torino, Italy