A Phase 1 Study of XL019 in Adults With Polycythemia Vera - Full Text View

Sponsored by:	Exelixis
Information provided by:	Exelixis
ClinicalTrials.gov Identifier:	NCT00595829

Purpose

The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor XL019 administered orally in adults with Polycythemia Vera.

Condition	Intervention	Phase
Polycythemia Vera	Drug: XL019	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Polycythemia Vera

Further study details as provided by Exelixis:

Primary Outcome Measures:

Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) [ Time Frame: Assessed at each visit ] [ Designated as safety issue: Yes ]
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019 [ Time Frame: Assessed at periodic visits ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: No ]
Evaluate preliminary efficacy of XL019 [ Time Frame: Assessed weekly or bi-weekly ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: XL019 XL019 capsules administered orally

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The subject has a diagnosis of polycythemia vera (PV), and has failed, or is intolerant of, standard therapies or refuses to take standard medications.
The subject is ≥18 years old.
The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
The subject has adequate organ function.
Subjects who have received phlebotomy due to PV must have documented phlebotomy history for 12 weeks prior to enrollment.
The subject has the capability of understanding the informed consent document and has signed the informed consent document.
Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
Female subjects of childbearing potential must have a negative pregnancy test at screening.
The subject has had no other diagnosis of malignancy or evidence of other malignancey for 2 years prior to screening for this study (except non-melanoma skin cancer or in situ carcinoma of the cervix).

Exclusion Criteria:

The subject has received treatment for PV within 14 days prior to first dose of XL019
The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within 3 months, or cardiac arrhythmias.
The subject is pregnant or breastfeeding.
The subject is known to be positive for the human immunodeficiency virus (HIV).
The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595829

Contacts

Contact: Exelixis Contact Line

1-866-939-4041

Locations

United States, California
UCLA School of Medicine, Center for Health Sciences	Recruiting
Los Angeles, California, United States, 90095
Contact: Lynn Tihopu 310-794-0738 ltihopu@mednet.ucla.edu
Principal Investigator: Ronald Paquette, MD
UCSF - Division of Hematology/Oncology	Recruiting
San Francisco, California, United States, 94143
Contact: Patrycija Olszynski 415-502-1564 polszynski@medicine.ucsf.edu
Principal Investigator: Neil Shah, MD, PhD
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute	Recruiting
Tampa, Florida, United States, 33612
Contact: Debra VanDonkelaar 813-745-4626 debra.vandonkelaar@moffitt.org
Principal Investigator: Lubomir Sokol, MD
United States, Michigan
University of Michigan Health System	Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Moshe Talpaz, MD
United States, New York
Weill Cornell Medical College	Recruiting
New York, New York, United States, 10065
Principal Investigator: Richard Silver, MD

Sponsors and Collaborators

Exelixis

More Information

Responsible Party:	Exelixis, Inc. ( Lynne Bui, MD/Senior Director, Clinical Research )
Study ID Numbers:	XL019-002
Study First Received:	January 7, 2008
Last Updated:	October 20, 2008
ClinicalTrials.gov Identifier:	NCT00595829
Health Authority:	United States: Food and Drug Administration

Keywords provided by Exelixis:

Polycythemia Vera
PV

Study placed in the following topic categories:

Polycythemia Vera
Polycythemia
Hematologic Diseases

Myeloproliferative Disorders
Polycythemia vera
Bone Marrow Diseases

ClinicalTrials.gov processed this record on January 16, 2009