MEDSIR has a new trial on board! First site active!
On June 19th 2020, the PATHFINDER study was approved by AEMPS and INFARMED and enrolment opened with the first site activation; IOB-QuironSalud Barcelona.
The PATHFINDER study is a multicenter, open-label, non-comparative, three-arm, phase IIa trial of ipatasertib (gdc-0068) in combination with non-taxane chemotherapy agents for taxane-pretreated unresectable locally advanced or metastatic triple-negative breast cancer patients (TNBC).
A run-in phase for safety and tolerability of ipatasertib (GDC-0068) in combination with capecitabine, eribulin, or carboplatin plus gemcitabine will be conducted as an initial step of the non-comparative phase IIa study where the subjects will be assigned in groups of 3. Patients will be followed to observe if they experience any significant toxicity during the two first cycles.
PATHFINDER is focused to evaluate the safety and tolerability of ipatasertib (GDC-0068) in combination with capecitabine, eribulin, or carboplatin plus gemcitabine in the ITT population of patients with taxane-pretreated unresectable locally advanced or metastatic TNBC. As well, as a second objective of the study, the efficacy of the combinations will be evaluated.
We believe that this trial represents a great opportunity for a target population with TNBC, associated with an aggressive natural history and poor clinical outcomes, and where few treatment options currently exist.
This study is expected to include the participation of 17 different sites in Spain and Portugal and overall enrolment of 54 patients (18 subjects on each arm).
From MedSIR, we would like to thank all the study investigators for their interest in participating in the PATHFINDER study.
Author: Marta Malo