Asian Phase II Study of INC424 in Patients With Primary Myelofibrosis (MF), Post-PV MF or Post-ET MF

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01392443
First received: July 11, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The objective of this study is to determine the efficacy of INC424 as assessed by reduction in spleen volume in patients with primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF. The safety and tolerability of INC424 and the effects of INC424 on patient reported outcomes and the duration of response as assessed by reduction in spleen volume will also be assessed.


Condition Intervention Phase
Primary Myelofibrosis (MF)
Post-Polycythemia Vera (PV) MF
Post-Essential Thrombocythemia (ET) MF
Drug: Ruxolitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-national Open-label Phase II Study of the JAK Inhibitor INC424 in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy by reduction in spleen volume [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety/tolerability of INC424 [ Time Frame: Frequency, duration and severity of adverse events ] [ Designated as safety issue: Yes ]
    based on frequency, duration and severity of adverse events

  • patient reported outcomes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    based on patient-directed quality of life questionnaires

  • Duration of response [ Time Frame: about 3 years ] [ Designated as safety issue: No ]
    reduction in spleen volume


Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib
Ruxolitinib is taken twice daily, unless instructed. Starting dose 15 mg BID for patients with baseline platelet count of 100,000/μL to 200,000/μL (inclusive) or 20 mg BID for those with baseline platelet count >200,000/μL (approximately 12 hours apart: morning and night), to be increased or decreased per standardized dosing paradigm.
Drug: Ruxolitinib
INC424 Tablet for oral use, provided in 5 mg bottles. The dosage strength is 5 mg/tablet INC424 phosphate (free base equivalent). Medication labels will be in the local language and comply with the legal requirements of each country. equivalent).
Other Name: INC424

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years or older
  2. Diagnosis of primary myelofibrosis (MF), post-polycythemia vera (PV) MF, or post-essential thrombocythemia (ET) MF
  3. Enlarged spleen, measuring 5 cm or greater from the costal margin
  4. Must have two or more of the following risk factors:

    1. Over 65 years old
    2. Have the following symptoms often associated with MF: loss of weight, fever, night sweats
    3. Have a low red blood cell count (anemia - hemoglobin < 10 g/dL)
    4. Have a high white blood cell count (history of white blood cell count > 25,000/uL)
    5. Have high circulating blasts (> or = 1%) as measured by blood tests
  5. Should have circulating blasts <10% (as measured by blood tests)
  6. Should be capable of self-care
  7. Should have adequate bone marrow reserve
  8. Should not have the option of stem cell transplantation
  9. Should discontinue any prior or ongoing treatment for myelofibrosis prior to entering the study
  10. Had no prior treatment with another JAK inhibitor

Exclusion Criteria:

  1. Does not have adequate liver or kidney function (as measured by blood tests)
  2. Has an active infection (bacterial, viral, etc.)
  3. Has active hepatitis A, B, or C or positive for HIV
  4. Has another cancer that needs active intervention
  5. Had a history of bleeding disorder
  6. Had a history of very low platelet counts (as measured by blood tests) not related to treatment of MF
  7. Had radiation of the spleen within 1 year of joining the study
  8. Does not have adequate heart function
  9. Sufficient time has elapsed between stopping previous treatment for MF and joining the study
  10. Females who are pregnant or breast-feeding
  11. Not able to sign informed consent
  12. Has any other active medical conditions that the doctor deems may compromise your safety or ability to join in the study

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392443

Locations
China, Beijing
Novartis Investigative Site
Beijing, Beijing, China, 100730
China, Guangdong
Novartis Investigative Site
Guangzhou, Guangdong, China, 510030
China, Hubei
Novartis Investigative Site
Wuhan, Hubei, China, 430030
China, Jiangsu
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Novartis Investigative Site
Suzhou, Jiangsu, China, 215006
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
China, Zhejiang
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310003
China
Novartis Investigative Site
Jinan, China, 250012
Novartis Investigative Site
Shanghai, China, 200025
Japan
Novartis Investigative Site
Nagoya-city, Aichi, Japan, 466-8560
Novartis Investigative Site
Fukuoka-city, Fukuoka, Japan, 812-8582
Novartis Investigative Site
Maebashi-city, Gunma, Japan, 371-8511
Novartis Investigative Site
Kanazawa, Ishikawa, Japan, 920-8641
Novartis Investigative Site
Tsu-city, Mie, Japan, 514-8507
Novartis Investigative Site
Suita-city, Osaka, Japan, 565-0871
Novartis Investigative Site
Bunkyo-ku, Tokyo, Japan, 113-8655
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-8582
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan, 160-0023
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 120-752
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 135-710
Novartis Investigative Site
Seoul, Korea, Republic of, 137-701
Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan, 833
Novartis Investigative Site
Taipei, Taiwan, 10048
Novartis Investigative Site
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01392443     History of Changes
Other Study ID Numbers: CINC424A2202
Study First Received: July 11, 2011
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration
China: State Food and Drug Administration (SFDA)
Japan: Ministry of Health, Labor and Welfare (MHLW)
Korea: Korea Food and Drug Administration (KFDA)
Taiwan: Department of Health

Keywords provided by Novartis:
INC424
Ruxolitinib
Myelofibrosis
MF

Additional relevant MeSH terms:
Primary Myelofibrosis
Polycythemia
Polycythemia Vera
Thrombocythemia, Essential
Thrombocytosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on April 23, 2014