Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
223 participants
INTERVENTIONAL
2010-09-30
2014-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Docetaxel & Oxaliplatin in Combination With Bevacizumab as First-Line Treatment in Subjects With Non-Small Cell Lung Cancer (NSCLC)
NCT00356122
Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
NCT00103389
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Previously Treated Advanced Non-small Cell Lung Cancer
NCT01620190
Docetaxel and Gemcitabine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
NCT00003762
CPI-613 and Docetaxel in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer
NCT03370159
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Docetaxel (NSCLC)
IV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
Docetaxel
PX-866 (NSCLC)
Oral 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
PX-866
Docetaxel (SCCHN)
IV docetaxel administered once every three weeks as per standard of care. Treatment continues until disease progression, unacceptable toxicity or withdrawal of consent.
Docetaxel
PX-866 (SCCHN)
Oral 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
PX-866
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Docetaxel
PX-866
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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)
* Creatinine level ≤1.5 x ULN
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cascadian Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Montefiore Medical Center
The Bronx, 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PX-866-002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.