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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Myelofibrosis (MF); Post-Polycythemia Vera (PV) MF; Post-Essential Thrombocythemia (ET) MF

Intervention: Ruxolitinib (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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.

Clinical Details

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

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

Primary outcome: Efficacy by reduction in spleen volume

Secondary outcome:

Safety/tolerability of INC424

patient reported outcomes

Duration of response

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Novartis Investigative Site, Jinan 250012, China

Novartis Investigative Site, Shanghai 200025, China

Novartis Investigative Site, Seoul 137-701, Korea, Republic of

Novartis Investigative Site, Kaohsiung 833, Taiwan

Novartis Investigative Site, Taipei 10048, Taiwan

Novartis Investigative Site, Taoyuan 333, Taiwan

Novartis Investigative Site, Nagoya-city, Aichi 466-8560, Japan

Novartis Investigative Site, Beijing, Beijing 100730, China

Novartis Investigative Site, Fukuoka-city, Fukuoka 812-8582, Japan

Novartis Investigative Site, Guangzhou, Guangdong 510030, China

Novartis Investigative Site, Maebashi-city, Gunma 371-8511, Japan

Novartis Investigative Site, Wuhan, Hubei 430030, China

Novartis Investigative Site, Kanazawa, Ishikawa 920-8641, Japan

Novartis Investigative Site, Nanjing, Jiangsu 210029, China

Novartis Investigative Site, Suzhou, Jiangsu 215006, China

Novartis Investigative Site, Seoul, Korea 110 744, Korea, Republic of

Novartis Investigative Site, Seoul, Korea 120-752, Korea, Republic of

Novartis Investigative Site, Seoul, Korea 135-710, Korea, Republic of

Novartis Investigative Site, Tsu-city, Mie 514-8507, Japan

Novartis Investigative Site, Suita-city, Osaka 565-0871, Japan

Novartis Investigative Site, Chengdu, Sichuan 610041, China

Novartis Investigative Site, Bunkyo-ku, Tokyo 113-8655, Japan

Novartis Investigative Site, Shinjuku-ku, Tokyo 160-0023, Japan

Novartis Investigative Site, Shinjuku-ku, Tokyo 160-8582, Japan

Novartis Investigative Site, Hangzhou, Zhejiang 310003, China

Additional Information

Starting date: August 2011
Last updated: August 29, 2014

Page last updated: August 23, 2015

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