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Study of PX-866 and Docetaxel in Solid Tumors

Information source: Oncothyreon Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Cancer (NSCLC); Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Intervention: Docetaxel (Drug); PX-866 (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Oncothyreon Inc.

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.

Clinical Details

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

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

Primary outcome: Progression Free Survival

Secondary outcome:

Objective response rate (ORR)

Incidence and severity of adverse events

Overall survival

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. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

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

Cancer Care Manitoba, Winnipeg, Manitoba R3E 0V9, Canada

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

Montefiore Medical Center, Bronx, New York 10467, 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

Columbia University Medical Center, New York, New York 10032, United States

New York University Medical Center, New York, New York 10016, United States

London Regional Cancer Program, London, Ontario N6A 4L6, Canada

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

Jewish General Hospital, Montreal, Quebec H3T1E2, Canada

CHUS Hopital Fleurimont, Sherbrooke, Quebec J1H 5N4, Canada

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

Additional Information

Starting date: September 2010
Last updated: May 19, 2015

Page last updated: August 23, 2015

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