Know Cancer

or
forgot password

A Phase I/II, Open-Label Study Evaluating Twice-Daily Administration of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Primary Myelofibrosis, Post-Polycythemia Vera, Post-Essential Thrombocythemia Myelofibrosis

Thank you

Trial Information

A Phase I/II, Open-Label Study Evaluating Twice-Daily Administration of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis


Inclusion Criteria:



- Diagnosis of PMF or post-ETIPV MF as per revised World Health Organization (WHO)
criteria (Section 16.4, Appendix 3).

- High-risk or Intermediate-2 risk MF (as defined by the International Prognostic
Scoring System [IPSS]; Section 16.6, Appendix 5); or Intermediate-1 risk MF (IPSS)
associated with symptomatic splenomegaly/hepatomegaly and/or unresponsive to
available therapy.

- Must be at least 18 years of age with life expectancy of ≥ 12 weeks.

- Must be able to provide informed consent and be willing to sign an informed consent
form.

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or
2 (Section 16.3, Appendix 2).

- Must have evidence of acceptable organ function within 7 days of initiating study
drug as evidenced by the following:

- SGOT (AST) or SGPT (ALT) less than or equal 2.5 x upper limit of normal(ULN) (or less
than or equal to 5 x ULN if in the investigator's opinion the elevation is due to
extramedullary hematopoiesis)

- Direct Bilirubin less than or equal to 2.0 x ULN

- Serum creatinine less than or equal to 2.5 x ULN

- Absolute neutrophil count ≥ 500/µL

- Platelet count ≥ 50,000/µL

- Females of childbearing potential must have a negative pregnancy test within 4 days
of initiating study drug.

Exclusion Criteria:

- Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g.,
thalidomide), immunosuppressive therapy, corticosteroids >10 mg/day prednisone or
equivalent, or growth factor treatment (e.g., erythropoietin) within 14 days prior to
initiation of study drug.

- Incomplete recovery from major surgery within four weeks of study entry.

- Radiation therapy within four weeks of study entry.

- Women of childbearing potential, unless surgically sterile for at least 3 months
(i.e., hysterectomy), OR postmenopausal for at least 12 months (FSH > 30 U/mL), OR
unless they agree to take appropriate precautions to avoid pregnancy (with at least
99% certainty) from screening through end of study. Permitted methods for preventing
pregnancy must be communicated to study subjects and their understanding confirmed.

- Men who partner with a woman of childbearing potential, unless they agree to take
appropriate precautions to avoid pregnancy (with at least 99% certainty) from
screening through to the end of study. Permitted methods for preventing pregnancy
must be communicated to study subjects and their understanding confirmed.

- Females who are pregnant or are currently breastfeeding.

- Known positive status for HIV.

- Positive serologic testing for hepatitis B (HBsAg and HBcAb total) and hepatitis C
(anti-HCV)

- Diagnosis of another malignancy unless free of disease for at least three years
following therapy with curative intent. Patients with early-stage basal cell or
squamous cell skin cancer, cervical intraepithelial neoplasia, cervical carcinoma in
situ or superficial bladder cancer may be eligible participate at the Investigator's
discretion.

- Any acute active infection.

- Cardiac dysrhythmias requiring treatment, or prolongation of the QTc (Fridericia)
interval to >480 at pre-study screening, unless attributable to pre-existing bundle
branch block.

- Presence of ≥ grade 2 peripheral neuropathy.

- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or
4), uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident,
or pulmonary embolism within 3 months prior to initiation of study drug.

- Uncontrolled intercurrent illness or any concurrent condition that, in the
Investigator's opinion, would jeopardize the safety of the patient or compliance with
the protocol.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety of CYT387 by characterization and relationship of adverse events, affects on vital signs and laboratory parameters, and QTc intervals as measured by electrocardiogram (ECG)

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Mark Kowalski, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

YM Biosciences Inc.

Authority:

United States: Food and Drug Administration

Study ID:

YM387-II-02

NCT ID:

NCT01423058

Start Date:

August 2011

Completion Date:

December 2014

Related Keywords:

  • Primary Myelofibrosis
  • Post-Polycythemia Vera
  • Post-Essential Thrombocythemia Myelofibrosis
  • Primary Myelofibrosis
  • Polycythemia
  • Polycythemia Vera
  • Thrombocythemia, Essential
  • Thrombocytosis

Name

Location

Mayo Clinic Jacksonville, Florida  32224
Mayo Clinic Scottsdale, Arizona  
Huntsman Cancer Institute at the University of Utah Salt Lake City, Utah  84112
MD Anderson Cancer Center, The University of Texas Houston, Texas  77030