Spots Global Cancer Trial Database for Study of PX-866 and Docetaxel in Solid Tumors
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Trial Identification
Brief Title: Study of PX-866 and Docetaxel in Solid Tumors
Official Title: Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
Study ID: NCT01204099
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint Louis, Missouri, United States
New Mexico Cancer Care Alliance, Albuquerque, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
New York Oncology, Hematology, Latham, New York, United States
Beth Israel Hospital, New York, New York, United States
New York University Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Northwest Cancer Specialists, Tualatin, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Texas Oncology - South Austin, Austin, Texas, United States
Mary Crowley Cancer Center, Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Oncology and Hematology Associates of SW Virginia, DBA Blue Ridge Cancer Care, Christiansburg, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Virginia Oncology Associates, Newport News, Virginia, United States
Columbia Basin Hematology & Oncology, Kennewick, Washington, United States
Medical Oncology Associates, Spokane, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge, Yakima, Washington, United States
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
London Regional Cancer Program, London, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
CHUS Hopital Fleurimont, Sherbrooke, Quebec, Canada
Contact Details
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