A Phase 1 Study of XL019 in Adults With Polycythemia Vera

NCT00595829 | Terminated Phase 1

• 1 other identifier: XL019-002
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 5

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.

Conditions

Polycythemia Vera

Keywords

Polycythemia Vera; PV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: XL019

Interventions

XL019 DRUG

XL019 capsules administered orally

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exelixis: lead

Study Sites (5)

UCLA School of Medicine, Center for Health Sciences

Los Angeles, California, 90095, United States

Location

UCSF - Division of Hematology/Oncology

San Francisco, California, 94143, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Polycythemia Vera

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (5)