Study of PX-866 and Docetaxel in Solid Tumors

May 14, 2018 updated by: Cascadian Therapeutics Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

223

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • Jewish General Hospital
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS Hopital Fleurimont
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Escondido, California, United States, 92025
        • Southwest Cancer Care
      • Pleasant Hill, California, United States, 94523
        • Bay Area Cancer Research Group, LLC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
      • Denver, Colorado, United States, 80220
        • Eastern Colorado Health Care System - Denver VA
    • Florida
      • Holiday, Florida, United States, 34619
        • Cancer Center of Pasco-Pinellas
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • John Hopkins University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • New Mexico Cancer Care Alliance
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Latham, New York, United States, 12110
        • New York Oncology, Hematology
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • New York University Medical Center
      • New York, New York, United States, 10003
        • Beth Israel Hospital
    • Oregon
      • Tualatin, Oregon, United States, 97062
        • Northwest Cancer Specialists
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Austin, Texas, United States, 78745
        • Texas Oncology - South Austin
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75201
        • Mary Crowley Cancer Center
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • Oncology and Hematology Associates of SW Virginia, DBA Blue Ridge Cancer Care
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
    • Washington
      • Kennewick, Washington, United States, 99336
        • Columbia Basin Hematology & Oncology
      • Spokane, Washington, United States, 99208
        • Medical Oncology Associates
      • Yakima, Washington, United States, 98902
        • Yakima Valley Memorial Hospital/North Star Lodge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Docetaxel
Other Names:
  • taxotere
Experimental: 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.
Drug: Docetaxel
Other Names:
  • taxotere
Drug: PX-866
Active Comparator: 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.
Drug: Docetaxel
Other Names:
  • taxotere
Experimental: 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.
Drug: Docetaxel
Other Names:
  • taxotere
Drug: PX-866

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response rate (ORR)
Time Frame: 42 days
42 days
Incidence and severity of adverse events
Time Frame: 42 days
42 days
Overall survival
Time Frame: 42 days
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cascadian Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 17, 2010

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PX-866-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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