Extended Access of Momelotinib in Adults With Myelofibrosis

Overview

About this study

The primary objective of this study is to provide extended access of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in Gilead sponsored studies GS-US-352-0101 (NCT01969838), GS-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), who are currently receiving treatment with MMB (available as 100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Currently enrolled in Studies GS-US-352-0101, GS-US-352-1214, or GS-US-352-1154 or SRA-MMB-301.
Did not discontinue treatment with MMB for any reason while enrolled in Studies GS-US-352-0101, GS-US-352-1214, GS-US-352-1154, or SRA-MMB-301
A negative serum or urine pregnancy test is required for female subjects of childbearing potential.
Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
Any Grade 3 or 4 (CTCAE Version 4.03) non-hematologic toxicity in the prior study that the investigator considers related to previous MMB use must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from last MMB administration to Day 1 of this study.
Any AE requiring MMB interruption during the prior study must have resolved, reverted to Grade 1, or reverted to baseline within the 30 days from last MMB administration to Day 1 of this study.
Ability and agreement to attend protocol-specified visits at the study site.
Able to comprehend and willing to sign the informed consent form.

Exclusion Criteria:

Known hypersensitivity to MMB, its metabolites, or formulation excipient.
Incomplete recovery from major surgery prior to Day 1 of this study.
Pregnant or lactating females.
Presence of ≥ Grade 3 (CTCAE Version 4.03) peripheral neuropathy.
Known positive status for human immunodeficiency virus (HIV).
Known chronic active or acute viral hepatitis A, B, or C infection.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Naseema Gangat, M.B.B.S.	Closed for enrollment	Contact information: Brooke Leverson CCRP (507) 293-1665 Leverson.Brooke@mayo.edu
Jacksonville, Fla. Mayo Clinic principal investigator Candido Rivera Linares, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office 855-776-0015
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Jeanne Palmer, M.D.	Closed for enrollment	Contact information: Christine Reed Pease (480) 342-6068 ReedPease.Christine@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Naseema Gangat, M.B.B.S.

Closed for enrollment

Contact information:

Brooke Leverson CCRP

(507) 293-1665

Leverson.Brooke@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Candido Rivera Linares, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Closed for enrollment

Contact information:

Christine Reed Pease

(480) 342-6068

ReedPease.Christine@mayo.edu

More information

Publications

Publications are currently not available

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