Study of PX-866 and Docetaxel in Solid Tumors
Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors
1 other identifier
interventional
223
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2010
Typical duration for phase_1
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 15, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMay 16, 2018
April 1, 2015
3.3 years
September 15, 2010
May 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival
42 days
Secondary Outcomes (3)
Objective response rate (ORR)
42 days
Incidence and severity of adverse events
42 days
Overall survival
42 days
Study Arms (4)
Docetaxel (NSCLC)
ACTIVE COMPARATORIV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
PX-866 (NSCLC)
EXPERIMENTALOral PX-866 administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
Docetaxel (SCCHN)
ACTIVE COMPARATORIV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
PX-866 (SCCHN)
EXPERIMENTALOral PX-866, administered daily at the RD in combination with IV docetaxel administered once every three weeks on a 21 day cycle. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
Interventions
Eligibility Criteria
You may qualify if:
- At least 18 years at time of consent
- Agrees to use a medically accepted form of contraception from the time of consent to completion of all follow up study visits
- If female of child bearing potential, negative pregnancy test (not required for post menopausal females)
- Signed an informed consent document that has been approved by an institutional review board or independent ethics committee (IRB/IEC)
- Has either locally advanced, recurrent, or metastatic NSCLC for which they have received at least 1 and no more than 2 prior systemic treatment regimens that may include up to 1 platinum based chemotherapy regimen and/or an epidermal growth factor receptor (EGFR) inhibitor OR locally advanced, recurrent or metastatic SCCHN for which they have received at least one and no more than two prior systemic treatment regimens.
- Measurable disease per Response Evaluation Criteria In Solid Tumors
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- In the opinion of the clinical investigator, life expectancy \>3 months
- Adequate hematologic function as defined by:
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥1500 cells/µL
- Platelets ≥100,000/µL
- Adequate hepatic function as defined by the following:
- Bilirubin ≤ ULN
- Aspartate aminotransaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤1.5 x upper limit of normal (ULN)
- +1 more criteria
You may not qualify if:
- Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- Is breastfeeding
- Treatment with any systemic chemotherapy, epidermal growth factor receptor (EGFR) inhibitor, radiation or experimental agent within 4 weeks of study drug dosing. Washout period following palliative radiation should be discussed with the study medical monitor
- Previous treatment with docetaxel except for patients in Phase 2 who received a docetaxel containing regimen as part of adjuvant or neoadjuvant therapy which was completed at least 6 months prior to study drug dosing
- Previous treatment with a phosphatidylinositol 3 kinase (PI 3K) inhibitor
- Known human immunodeficiency virus (HIV)
- Known or suspected clinically active brain metastases. Previously treated and stable brain metastases are allowable. Stable brain metastases are defined as no change on CT scan or MRI for minimum of two months AND no change in steroid dose for a minimum of four weeks, unless change due to intercurrent infection or other acute event
- Grade \>2 peripheral neuropathy, as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.02
- Any other significant medical or psychiatric condition that in the opinion of the investigator renders the patient inadequate for participation
- History of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Southwest Cancer Care
Escondido, California, 92025, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, 94523, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Eastern Colorado Health Care System - Denver VA
Denver, Colorado, 80220, United States
Cancer Center of Pasco-Pinellas
Holiday, Florida, 34619, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
John Hopkins University
Baltimore, Maryland, 21231, United States
Washington University
St Louis, Missouri, 63110, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
New York Oncology, Hematology
Latham, New York, 12110, United States
Beth Israel Hospital
New York, New York, 10003, United States
New York University Medical Center
New York, New York, 10016, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Northwest Cancer Specialists
Tualatin, Oregon, 97062, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Oncology - South Austin
Austin, Texas, 78745, United States
Mary Crowley Cancer Center
Dallas, Texas, 75201, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Oncology and Hematology Associates of SW Virginia, DBA Blue Ridge Cancer Care
Christiansburg, Virginia, 24073, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Columbia Basin Hematology & Oncology
Kennewick, Washington, 99336, United States
Medical Oncology Associates
Spokane, Washington, 99208, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902, United States
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
CHUS Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2010
First Posted
September 17, 2010
Study Start
September 1, 2010
Primary Completion
December 1, 2013
Study Completion
February 1, 2014
Last Updated
May 16, 2018
Record last verified: 2015-04