A Phase 1 Study of XL019 in Adults With Polycythemia Vera

Phase 1

Terminated

• Conditions: Polycythemia Vera
• Interventions: Drug: XL019

• Registration Number: NCT00595829
• Lead Sponsor: Exelixis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	XL019	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV)	Assessed at each visit
Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019	Assessed at periodic visits

Secondary Outcome Measures

Name	Time	Method
Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV	Assessed during periodic visits
Evaluate preliminary efficacy of XL019	Assessed weekly or bi-weekly

Trial Locations

Locations (5)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

UCSF - Division of Hematology/Oncology; 🇺🇸 San Francisco, California, United States

UCLA School of Medicine, Center for Health Sciences; 🇺🇸 Los Angeles, California, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States