A Study to Evaluate the Safety and Tolerability of Oral Ixazomib in Scleroderma-related Lung Disease Patients

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability of ixazomib in patients with scleroderma.

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:

  • Male and female patients, age ≥ 18 years at time of signing informed written consent.

Exclusion Criteria:

  • Clinically significant pulmonary hypertension, based on any of the following criteria:
    • Receiving treatment for pulmonary arterial hypertension; or
    • Evidence for any form of pulmonary hypertension as determined by previous right heart catheterization. Pulmonary arterial hypertension is defined as a mean pulmonary artery pressure ≥ 20 mmHg at rest, a mean pulmonary capillary wedge pressure ≤ 15 mmHg, and the pulmonary vascular resistance ≥ 3 Wood units; or
    • Doppler echocardiography within the 6 months before study Day 1 reporting an estimated right ventricular systolic pressure of >40 mm Hg if subsequent confirmatory right heart catheterization has not been done.
  • Doppler echocardiography in the 6 months before study Day 1 showing evidence of right atrial or right ventricular enlargement or significant left ventricular dysfunction with left ventricular ejection fraction < 40%.
  • Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux (i.e., University of California, Los Angeles, Scleroderma Clinical Trial Consortium Gastrointestinal Scale, 2.0 [UCLA SCTC GIT 2.0] reflux score >1.00).
  • Known esophageal dysfunction with esophageal stricture sufficient to limit the ability to swallow oral medication.
  • Prior history of renal crisis.

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

W Griffing, M.D.

Open for enrollment

Contact information:

Temeka Simmons

(480) 301-9224

Simmons.Temeka@mayo.edu

More information

Publications

Publications are currently not available
.

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