Trial record 1 of 193 for:    "polycythemia vera"
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A Phase 1 Study of XL019 in Adults With Polycythemia Vera

This study has been terminated.
Sponsor:
Information provided by:
Exelixis
ClinicalTrials.gov Identifier:
NCT00595829
First received: January 7, 2008
Last updated: October 1, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Polycythemia Vera
Drug: XL019
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Exelixis:

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

Secondary Outcome Measures:
  • Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV [ Time Frame: Assessed during periodic visits ] [ Designated as safety issue: No ]
  • Evaluate preliminary efficacy of XL019 [ Time Frame: Assessed weekly or bi-weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: XL019
XL019 capsules administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595829

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

No publications provided

Responsible Party: Chunyan Song, MD/Senior Manager, Clinical Research, Exelixis, Inc.
ClinicalTrials.gov Identifier: NCT00595829     History of Changes
Other Study ID Numbers: XL019-002
Study First Received: January 7, 2008
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
Polycythemia Vera
PV

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on April 23, 2014