ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1 Study of XL019 in Adults With Polycythemia Vera

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00595829
Recruitment Status : Terminated
First Posted : January 16, 2008
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Exelixis

January 7, 2008
January 16, 2008
August 21, 2015
December 2007
February 2009   (Final data collection date for primary outcome measure)
  • Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) [ Time Frame: Assessed at each visit ]
  • Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019 [ Time Frame: Assessed at periodic visits ]
  • Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) [ Time Frame: Assessed at each visit ]
  • Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019
Complete list of historical versions of study NCT00595829 on ClinicalTrials.gov Archive Site
  • Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV [ Time Frame: Assessed during periodic visits ]
  • Evaluate preliminary efficacy of XL019 [ Time Frame: Assessed weekly or bi-weekly ]
Same as current
Not Provided
Not Provided
 
A Phase 1 Study of XL019 in Adults With Polycythemia Vera
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Polycythemia Vera
Drug: XL019
XL019 capsules administered orally
Experimental: 1
Intervention: Drug: XL019
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
63
February 2009
February 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00595829
XL019-002
Not Provided
Not Provided
Not Provided
Exelixis
Exelixis
Not Provided
Not Provided
Exelixis
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP