A Phase 1 Study of XL019 in Adults With Polycythemia Vera

August 19, 2015 updated by: Exelixis

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV
Time Frame: Assessed during periodic visits
Assessed during periodic visits
Evaluate preliminary efficacy of XL019
Time Frame: Assessed weekly or bi-weekly
Assessed weekly or bi-weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Exelixis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

January 7, 2008

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

August 21, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XL019-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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