Status:
COMPLETED
Study of PX-866 and Docetaxel in Solid Tumors
Lead Sponsor:
Cascadian Therapeutics Inc.
Conditions:
Non Small Cell Lung Cancer (NSCLC)
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 determi...
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. Pha...
Eligibility Criteria
Inclusion
- 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)
- Creatinine level ≤1.5 x ULN
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
223 Patients enrolled
Trial Details
Trial ID
NCT01204099
Start Date
September 1 2010
End Date
February 1 2014
Last Update
May 16 2018
Active Locations (33)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Southwest Cancer Care
Escondido, California, United States, 92025
3
Bay Area Cancer Research Group, LLC
Pleasant Hill, California, United States, 94523
4
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045