Trial Search Results

Efficacy and Safety of Simtuzumab in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) on bone marrow fibrosis either alone or in combination with ruxolitinib in participants with Primary myelofibrosis (PMF) and Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis (ET/PV MF).

The study is designed as a two stage trial. In the stage 1, patients will be randomized into two cohorts to receive either 200 or 700 mg of study drug. In the stage 2, patients on ruxolitinib will be randomized to receive either 200 or 700 mg of study drug.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Intervention(s):

  • Drug: Simtuzumab
  • Drug: Ruxolitinib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Must be diagnosed with PMF or post ET/PV MF with intermediate-1, intermediate-2 or
   high risk disease according to the IWG prognostic scoring system, or if with low risk
   disease then with symptomatic splenomegaly that is ≥ 10 cm below left costal margin by
   physical exam.

   - Must have adequate organ function as demonstrated by the following:

   - ALT (SGPT) and/or AST (SGOT) ≤ 2.5x upper limit of normal (ULN), or ≤ 4x ULN (if upon
   judgment of the treating physician, it is believed to be due to extramedullary
   hematopoiesis [EMH] related to MF);

   - Direct bilirubin ≤ 1.5 x ULN; or ≤ 2x ULN (if upon judgment of the treating physician,
   it is believed to be due to extramedullary hematopoiesis [EMH] related to MF);

   - Serum creatinine ≤ 2.5 mg/dL. 2.5 mg/dL.

   - In Stage 2, subjects must be on ruxolitinib for at least 8 weeks and on a stable dose
   for at least 4 weeks.

   - ECOG performance status (PS) ≤ 2

   - Treatment-related toxicities from prior therapies must have resolved to Grade ≤ 1

   - Women of childbearing potential and men must agree to using one medically approved
   (ie, mechanical or pharmacological) contraceptive measure and have their partners
   agree to an additional barrier method of contraception for the duration of the study
   and for 90 days after the last administration of study drug. Please refer to Section
   11 for a definition of female of child bearing potential and a list of acceptable
   contraceptive methods for this study.

Exclusion Criteria:

   - Any serious medical condition or psychiatric illness that would prevent, (as judged by
   the treating physician) the subject from signing the informed consent form or any
   condition, including the presence of laboratory abnormalities, which places the
   subject at unacceptable risk if he/she were to participate in the study or confounds
   the ability to interpret data from the study.

   - Pregnant or lactating.

   - Known history of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.

   - History or presence of any form of cancer within the 3 years prior to enrollment, with
   the exception of excised basal cell or squamous cell carcinoma of the skin, or
   cervical carcinoma in situ or breast carcinoma in situ that has been excised or
   resected completely and is without evidence of local recurrence or metastasis.

   - Participation in an investigational drug or device trial within 2 weeks prior to study
   Day 1 or within 5 times the half-life of the investigational agent in the other
   clinical study, if known.

   - Use of any cytotoxic chemotherapeutic agents (eg, hydroxyurea), corticosteroids
   (prednisone ≤ 10 mg/day or corticosteroid equivalent is allowed), or immune modulators
   (eg, thalidomide) within 2 weeks and interferon use within 4 weeks prior to study Day
   1.

   - Symptomatic congestive heart failure (New York Heart Association Classification >
   Class II), unstable angina, or unstable cardiac arrhythmia requiring medication.

   - History of surgery within 2 weeks prior to enrollment or anticipated surgery during
   the study period.

   - Any other condition that might reduce the chance of obtaining data required by the
   protocol or that might compromise the ability to give truly informed consent.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting