Pomalidomide for Cough in Patients With Idiopathic Pulmonary Fibrosis

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of pomalidomide over a 12 week duration in the treatment of chronic cough in patients with IPF as measured by a Cough Symptom Diary, Visual Analogue Scale for Cough Severity, Leicester Cough Questionnaire, St. George Respiratory Questionnaire, Cough-Specific Quality-of-Life Questionnaire, and adverse event reporting. There will be an option open to participants, who respond to treatment by meeting pre-determined criteria, to remain in the study for an additional 9 months or for a total of 54 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Celgene Corporation
• Treatments: Pomalidomide; Thalidomide

Criteria

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. >18 and < 75 years old at the time of signing the informed consent form.

3. Able to adhere to the study visit schedule and other protocol requirements.

4. Have a diagnosis of Idiopathic Pulmonary Fibrosis in accordance to American Thoracic Society guidelines.

5. Persistent cough:

• as defined by a cough that adversely affects the patient's quality of life and has been present for at least 3 months.

6. Laboratory test results within these ranges:

• Absolute neutrophil count >2 x 103/ul

• Platelet count >100,000 /mm³

• Serum creatinine < 2.0 mg/dL

• Total bilirubin < 1.5 mg/dL

7. Diffusion capacity > 25%predicted

8. Forced vital capacity <80% predicted • AST (SGOT) and ALT (SGPT) < 2 x ULN

8. Able to take aspirin (81 or 325 mg) daily as prophylactic anti-coagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

2. Females of child-bearing potential defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

3. 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.

4. Use of any other experimental drug or therapy within 28 days of baseline.

5. Known hypersensitivity to thalidomide or lenalidomide.

6. Any prior use of thalidomide, lenalidomide or pomalidomide (CC-4047).

7. Known positive for HIV or infectious hepatitis, type A, B or C.

8. History of deep venous thrombosis

9. History of pulmonary embolism

10. Use of the following anti-tussive agents must be discontinued 14 days prior to their baseline visit. -

1. prednisone 2. narcotic anti-tussives 3. baclofen 4. neurontin 11. Treatment for infection or acute exacerbation within past 3 months