Study of PX-866 and Docetaxel in Solid Tumors

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01204099
• Other study ID #: PX-866-002
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 2010
• Est. completion date: February 2014

Study information

• Verified date: April 2015
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Non Small Cell Lung Cancer (NSCLC)
• Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Intervention

Drug:
• Docetaxel

• PX-866

Locations

Country	Name	City	State
Canada	London Regional Cancer Program	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	CHUS Hopital Fleurimont	Sherbrooke	Quebec
Canada	Cancer Care Manitoba	Winnipeg	Manitoba
United States	New Mexico Cancer Care Alliance	Albuquerque	New Mexico
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Texas Oncology - South Austin	Austin	Texas
United States	John Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Montefiore Medical Center	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Oncology and Hematology Associates of SW Virginia, DBA Blue Ridge Cancer Care	Christiansburg	Virginia
United States	Mary Crowley Cancer Center	Dallas	Texas
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Eastern Colorado Health Care System - Denver VA	Denver	Colorado
United States	Southwest Cancer Care	Escondido	California
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Cancer Center of Pasco-Pinellas	Holiday	Florida
United States	Columbia Basin Hematology & Oncology	Kennewick	Washington
United States	New York Oncology, Hematology	Latham	New York
United States	Beth Israel Hospital	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	New York University Medical Center	New York	New York
United States	Virginia Oncology Associates	Newport News	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Bay Area Cancer Research Group, LLC	Pleasant Hill	California
United States	Washington University	Saint Louis	Missouri
United States	Medical Oncology Associates	Spokane	Washington
United States	Northwest Cancer Specialists	Tualatin	Oregon
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cascadian Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		42 days
Secondary	Objective response rate (ORR)		42 days
Secondary	Incidence and severity of adverse events		42 days
Secondary	Overall survival		42 days