Pancreatic Cancer Clinical Trial
Official title:
A Phase 1b Study of the Safety and Tolerability of Ruxolitinib in Combination With Gemcitabine With or Without Nab-Paclitaxel in Subjects With Advanced Solid Tumors
This is a study of ruxolitinib in combination with gemcitabine with or without nab-paclitaxel
administered to patients with advanced or metastatic pancreatic cancer. The study will be
conducted in two parts.
Part 1 of the study will evaluate the safety, tolerability and pharmacokinetics (PK) of
ruxolitinib when given as described to patients with advanced or metastatic pancreatic
cancer. A goal of Part 1 will be to identify the maximally tolerated dose (MTD) of
ruxolitinib when given with gemcitabine with or without nab-paclitaxel. This dose will be
selected for use in Part 2 of the study.
Part 2 of the study will further evaluate the safety, tolerability, PK and preliminary
clinical activity of ruxolitinib at the dose defined in Part 1 used in combination with
gemcitabine with or without nab-paclitaxel in subjects with advanced or metastatic pancreatic
cancer.
After multiple challenges of trial conduct, by mutual agreement between investigators and
sponsor, dose escalation ended after Cohort B1, RUX 10 mg twice daily (BID) - GCSF in October
2014. Therefore, the MTD was not reached. No safety issues led to the decision to stop
further enrollment.
Because of the early study termination, samples for pharmacokinetics and pharmacodynamics,
and computed tomography for tumor burden were collected, but not analyzed; analysis data are
not available. The data cutoff for this posting is 22 SEP 2015. As of the data cutoff, 1
subject was receiving treatment in the study and had been enrolled for 47 weeks. This subject
had their end of treatment visit in AUG 2016. A comparison of this subjects' safety data
after the cutoff date showed no clinically meaningful differences (eg, adverse events)
compared with safety results that are summarized here.
n/a
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