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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
223
Progression Free Survival
Time frame: 42 days
Objective response rate (ORR)
Time frame: 42 days
Incidence and severity of adverse events
Time frame: 42 days
Overall survival
Time frame: 42 days
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Southwest Cancer Care
Escondido, California, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Eastern Colorado Health Care System - Denver VA
Denver, Colorado, United States
Cancer Center of Pasco-Pinellas
Holiday, Florida, United States
Cancer Center of Kansas
Wichita, Kansas, United States
John Hopkins University
Baltimore, Maryland, United States
Washington University
St Louis, Missouri, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
...and 23 more locations