Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
Phase 1: To determine the maximally tolerated dose (MTD) or recommended dose (RD) and any
potential efficacy of PX-866 in combination with docetaxel in patients with solid tumors.
Phase 2: To determine the antitumor activity and safety of PX-866 in combination with
docetaxel versus docetaxel alone in patients with NSCLC or SCCHN.
This is a Phase 1/2 open-label study. In the Phase 1 part of the study, PX-866 was given in
combination with docetaxel to patients with incurable locally advanced, recurrent or
metastatic cancer.
Phase 2 of the study is an open-label, randomized evaluation of the antitumor activity and
safety of PX-866, administered at the MTD/RD identified in Phase 1 (8mg daily), in
combination with docetaxel versus docetaxel alone in patients with locally advanced,
recurrent, or metastatic NSCLC (Group 1) or patients with locally advanced, recurrent, or
metastatic SCCHN (Group 2).
Group 1 (patients with locally advanced, recurrent, or metastatic NSCLC) is now closed to
enrollment.
All treatments will be administered on a 21-day cycle. Docetaxel 75 mg/m2 will be
administered IV on Day 1 of each 21-day cycle. PX-866 will be administered orally or via PEG
tube (if applicable) once per day on Days 1 to 21 of all treatment cycles in patients
randomized to the treatment arm containing PX-866.
Patients will be evaluated for progression approximately every 6 weeks. Patients with stable
disease (SD) or better, per investigator assessment, will receive repeat cycles of treatment
on a 21-day schedule until disease progression, unacceptable toxicity or withdrawal of
consent.
;
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