A Phase 1 Study of XL019 in Adults With Polycythemia Vera

Polycythemia Vera Clinical Trial

Official title:

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Polycythemia Vera

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00595829
• Other study ID #: XL019-002
• Status: Terminated
• Phase: Phase 1
• First received: January 7, 2008
• Last updated: August 19, 2015
• Start date: December 2007
• Est. completion date: February 2009

Study information

• Verified date: August 2015
• Source: Exelixis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

Intervention

Drug:
• XL019
XL019 capsules administered orally

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	UCLA School of Medicine, Center for Health Sciences	Los Angeles	California
United States	Weill Cornell Medical College	New York	New York
United States	UCSF - Division of Hematology/Oncology	San Francisco	California
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV)		Assessed at each visit	Yes
Primary	Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019		Assessed at periodic visits	Yes
Secondary	Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV		Assessed during periodic visits	No
Secondary	Evaluate preliminary efficacy of XL019		Assessed weekly or bi-weekly	No