Know Cancer

forgot password

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

Phase 1
18 Years
Not Enrolling
Myeloproliferative Disorders, Myelofibrosis, Polycythemia Vera, Thrombocythemia, Essential

Thank you

Trial Information

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

Inclusion Criteria:

- The subject has primary myelofibrosis (PMF), post-polycythemia vera MF, or
post-essential thrombocythemia MF and requires therapy, including subjects who have
received prior MF-directed therapy and relapsed or subjects with refractory disease;
or if newly diagnosed, then with intermediate or high risk according to the Lille
scoring system.

- The subject is unwilling to undergo or is not a candidate for peripheral stem
cell/bone marrow transplant.

- The subject is ≥18 years old.

- The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of

- The subject has adequate organ function.

- 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

- The subject has had no diagnosis of malignancy or evidence of other malignancy 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 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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the safety, tolerability, maximum tolerated dose, and dose-limiting toxicities of XL019 as a single agent when orally administered in subjects with PMF, post-PV MF, or post-ET MF.

Outcome Time Frame:

Assessed at periodic visits

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2007

Completion Date:

Related Keywords:

  • Myeloproliferative Disorders
  • Myelofibrosis
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Myeloproliferative Disorders
  • Primary Myelofibrosis
  • Myeloproliferative Disorders
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis



MD Anderson Cancer Center Houston, Texas  77030-4096
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Dana Farber Cancer Institute Boston, Massachusetts  02115
Mt. Sinai School of Medicine New York, New York  10029
UCSF - Division of Hematology/Oncology San Francisco, California  94143