Trial to Evaluate Safety and Tolerability of GP-2250 in Combination With Gemcitabine
brief summary
This is a phase 1 first in human, dose escalation trial of GP-2250 administered in combination with gemcitabine in subjects with advanced pancreatic cancer previously treated with 5-fluorouracil-based chemotherapy. Prior radiosensitization with gemcitabine, the use of 5-fluorouracil, FOLFIRINOX or Nab-paclitaxel/gemcitabine in the neoadjuvant setting, and prior pancreaticoduodenectomy (Whipple procedure) is allowed. If prior treatment with gemcitabine was at therapeutic doses, a minimum of 3 months must have elapsed since the end of such treatment. As a precursor to 5-FU use of capecitabine-based chemotherapy is also permitted.
detailed description
This trial used a Bayesian Optimal Interval (BOIN) dose escalation design of GP-2250 as a single-dose monotherapy (Cycle 1 only) followed by combination therapy with gemcitabine for Cohorts 1 through 5. Following implementation of Amendment 7 and beginning with dose Cohort 6 and all subsequent cohorts, the trial will use a 3+3 dose escalation design, and will continue as single-dose monotherapy (Cycle 1 only) followed by combination therapy with gemcitabine. Subjects will continue to receive treatment until disease progression assessed by RECIST V1.1 criteria, clinical disease progression as assessed by the Investigator, development of a dose limiting toxicity, unacceptable toxicity, subject request for withdrawal, Investigator assessment that risk outweighs benefit, or study closure by the Sponsor.
official title
Phase 1 Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GP-2250 With Gemcitabine in Advanced Unresectable or Metastatic Pancreatic Adenocarcinoma Following Progression on 5-FU-based Chemotherapy