NAPAGE: NAb-PAclitaxel and GEmcitabine in Advanced Soft Tissue Sarcoma
Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
Participant gender:
Summary
A clinical trial with biweekly regimen of gemcitabine and nab-paclitaxel for Soft tissue
sarcomas (STSs).
A Promising antitumor activity in patients with metastatic STS has been reported with
gemcitabine alone or in combination with taxanes including docetaxel and paclitaxel in
pre-treated patients.
Nab-paclitaxel is a 130-nm albumin-bound formulation of paclitaxel particles (Celgene,
Summit, NJ) which was designed to eliminate the toxicities associated with Cremophor®-EL.
Nab-paclitaxel at equal dose of paclitaxel showed increased antitumor activity, enhanced
endothelial cell transport and 33% higher intra-tumor paclitaxel concentration in preclinical
models of solid tumor xenografts promising an advantageous pharmacokinetic profile In
sarcoma, nab-paclitaxel demonstrated preclinical anti-tumor activity in rhabdomyosarcoma
xenograft model. Local relapsed tumors following paclitaxel treatment proved to be
paclitaxel-resistant but remained responsive to nab-paclitaxel.
These findings provide the rationale for further evaluation of nab-paclitaxel in combination
with gemcitabine for soft tissue sarcoma treatment.