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Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN)

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Trial Information

Phase 1/2 Study of PX-866 and Docetaxel in Patients With Solid Tumors


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.


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Time Frame:

42 days

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

PX-866-002

NCT ID:

NCT01204099

Start Date:

September 2010

Completion Date:

February 2013

Related Keywords:

  • Non Small Cell Lung Cancer (NSCLC)
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • PX-866
  • Non small cell lung cancer
  • solid tumors
  • Squamous cell cancer of the head and neck
  • docetaxel
  • NSCLC
  • taxotere
  • SCCHN
  • PI-3K
  • PI3 kinase
  • PI3K
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Lung Neoplasms
  • Head and Neck Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Colorado Cancer CenterDenver, Colorado  80262
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Virginia Oncology AssociatesNewport News, Virginia  23606
Montefiore Medical CenterBronx, New York  10467-2490
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Southwest Cancer CarePoway, California  92064
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
New York University Medical CenterNew York, New York  10016
Washington UniversitySt. Louis, Missouri  63110
Bay Area Cancer Research Group, LLCConcord, California  94520
Ut Southwestern Medical CenterDallas, Texas  75390
Columbia University Medical CenterNew York, New York  10032
Beth Israel HospitalNew York, New York  10003
Cancer Center of KansasWichita, Kansas  67214
New Mexico Cancer Care AllianceAlbuquerque, New Mexico  87106
Yakima Valley Memorial Hospital/North Star LodgeYakima, Washington  98902
Northwest Cancer SpecialistsPortland, Oregon  97225
Columbia Basin Hematology & OncologyKennewicke, Washington  99336
John Hopkins UniversityBaltimore, Maryland  21231
Mary Crowley Cancer CenterDallas, Texas  75246
Texas Oncology - Baylor Charles A. Sammons Cancer CenterDallas, Texas  75246
Marin Cancer Care, Inc.Greenbrae, California  94904
Virginia Cancer SpecialistsFairfax, Virginia  
Bronx Lebanon HospitalBronx, New York  11203
Eastern Colorado Health Care System - Denver VADenver, Colorado  80220
Cancer Center of Pasco-PinellasHoliday, Florida  34619
New York Oncology, HematologyLatham, New York  12110
Kaiser Permanante NorthwestPortland, Oregon  97227
Texas Oncology - South AustinAustin, Texas  78745
Oncology and Hematology Associates of SW Virginia, DBA Blue Ridge Cancer CareChristiansburg, Virginia  24073
Medical Oncology AssociatesSpokane, Washington  99208