A Phase 1 Study of XL019 in Adults With Polycythemia Vera

• Sponsor: Exelixis (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00595829
• Collaborator: (none)
• Enrollment: 3
• Locations: 5
• Arm: 1
• Duration (Months): 14.1
• Patients Per Site: 0.6
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycythemia Vera	Drug: XL019	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Polycythemia Vera
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: XL019; XL019 capsules administered orally

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) [Assessed at each visit]

2. Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019 [Assessed at periodic visits]

Secondary Outcome Measures

1. Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV [Assessed during periodic visits]

2. Evaluate preliminary efficacy of XL019 [Assessed weekly or bi-weekly]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UCLA School of Medicine, Center for Health Sciences	Los Angeles	California	United States	90095
2	UCSF - Division of Hematology/Oncology	San Francisco	California	United States	94143
3	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
4	University of Michigan Health System	Ann Arbor	Michigan	United States	48109
5	Weill Cornell Medical College	New York	New York	United States	10065

Sponsors and Collaborators

• Exelixis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Exelixis
• ClinicalTrials.gov Identifier: NCT00595829
• Other Study ID Numbers: XL019-002
• First Posted: Jan 16, 2008
• Last Update Posted: Aug 21, 2015
• Last Verified: Aug 1, 2015

• Keywords provided by Exelixis: Polycythemia Vera; PV
• Additional relevant MeSH terms: Polycythemia Vera; Polycythemia

Study Results

No Results Posted as of Aug 21, 2015