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Efficacy and Safety of GS-6624 in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01369498
First received: June 6, 2011
Last updated: October 22, 2014
Last verified: October 2014

June 6, 2011
October 22, 2014
June 2011
June 2014   (final data collection date for primary outcome measure)
Rate of clinical response as defined by reduction in bone marrow fibrosis score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Using the International Working Group criteria, determine the number of patients that respond to AB0024 ater 2 cycles of treatment [ Time Frame: 190 days ] [ Designated as safety issue: No ]
•To evaluate the efficacy of AB0024 as therapy for Primary Myelofibrosis (PMF) and Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (post-PV MF or post-ET MF). Best overall response will be categorized according to the International Working Group (IWG) Criteria. Efficacy will be measured by Rate of clinical response as defined by IWG criteria. Stable disease with improvement in bone marrow fibrosis score, clinical improvement, partial remission, or complete remission will be considered a response.
Complete list of historical versions of study NCT01369498 on ClinicalTrials.gov Archive Site
  • Rate of clinical response as defined by improvement in hemoglobin, platelet, or absolute neutrophil count [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Change in Myelofibrosis Symptoms Assessment Score [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Changes in cytokine levels [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Anti-GS-6624 antibody formation [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
To evaluate Safety and Efficacy of GS-6624 (AB0024) [ Time Frame: 190 days ] [ Designated as safety issue: No ]

To evaluate:

  • Incidence and severity of adverse events, as defined by Common Terminology Criteria for Adverse Events, v 4.03;
  • Change in bone marrow histology;
  • Change in Myelofibrosis Symptoms Assessment Score;
  • Change in cytokines levels;
  • Anti-AB0024 antibody formation.
Not Provided
Not Provided
 
Efficacy and Safety of GS-6624 in Adults With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis
A Phase 2 Study to Evaluate the Efficacy and Safety of GS-6624 in Adult Subjects With Primary, Post Polycythemia Vera or Post Essential Thrombocythemia Myelofibrosis

This study is to evaluate the efficacy and safety of 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelofibrosis
  • Drug: GS-6624
    GS-6624 200 mg or 700 mg administered intravenously over approximately 30 minutes every 2 weeks
    Other Name: AB0024
  • Drug: Ruxolitinib
    In stage 2, participants will be on a stable dose of ruxolitinib and will continue their treatment in combination with GS-6624
  • Experimental: GS-6624 200 mg
    Participants in stage 1 of study will receive GS-6624 200 mg for up to 28 weeks.
    Intervention: Drug: GS-6624
  • Experimental: GS-6624 700 mg
    Participants in stage 1 of study will receive GS-6624 700 mg for up to 28 weeks.
    Intervention: Drug: GS-6624
  • Experimental: GS-6624 200 mg+ruxolitinib
    In stage 2, participants on stable doses of ruxolitinib will receive GS-6624 200 mg for at least 24 weeks.
    Interventions:
    • Drug: GS-6624
    • Drug: Ruxolitinib
  • Experimental: GS-6624 700 mg+ruxolitinib
    In stage 2, participants on stable doses of ruxolitinib will receive GS-6624 700 mg for at least 24 weeks.
    Interventions:
    • Drug: GS-6624
    • Drug: Ruxolitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
September 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369498
AB0024-102
No
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Zung Thai, MD, PhD Gilead Sciences
Gilead Sciences
October 2014

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