Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP)

NCT02854761 | Unknown Phase 1

• 1 other identifier: CS-102
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates the safety and tolerability of the investigational drug EF-022 in the treatment of adult patients with Recurrent Respiratory Papillomatosis (RRP). Patients will be administered EF-022, either intramuscular or subcutaneous, for a period of 6 months. Preliminary effect of the drug on the disease will be evaluated by following the number and severity of the lesions in the respiratory tract and the effect on voice changes.

Conditions

Recurrent Respiratory Papillomatosis

Outcome Measures

Primary Outcomes (1)

• CTCAE v.4.03 criteria will constitute the primary safety endpoints to be monitored throughout this study

  6 months

Study Arms (2)

SC administration

EXPERIMENTAL

Subcutaneous (SC) administration of 500 ng of EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) once weekly, for 6 months

Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)

IM administration

EXPERIMENTAL

Intramuscular (IM) adminstration of 500 ng EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) once weekly for 6 months

Drug: EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)

Interventions

EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) DRUG

IM administration; SC administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with documented diagnosis of recurrent respiratory papillomatosis
• Patients with measurable disease
• Patients presenting at least one of the following severity criteria: Derkay score ≥ 8 , Voice handicap index (VHI) ≥11
• Adult male and female subjects, age of 18 and above (≥18 yrs)
• Patients with documentation on number of debulking procedures done during past 12 months
• Estimated expectancy time for next debulking procedure must be at least 3 months.
• Must be at least 4 weeks (\>4 weeks) since last treatment including cytotoxic therapy, biological or immunotherapy, anti-viral therapy, molecularly targeted therapy or steroid treatment.
• Must be at least 2 weeks (\>2weeks) since last NSAID treatment.
• Must have adequately recovered (to at least Grade 1 level) from adverse effects of prior therapies.
• Female of child bearing potential must have a negative pregnancy test and must be practicing an effective method of birth control
• Patients or their guardians must sign an informed consent indicating that they are aware of the investigational nature of this study

You may not qualify if:

• Patient on concurrent steroids or anti-inflammatory non steroid treatment.
• Active autoimmune disease
• Known major immunodeficiency
• Known to be Positive for HIV, Hepatitis B surface antigen, Hepatitis C antibody
• Have absolute neutrophil counts below 1.5X 10\^9/L
• Hemoglobin below 10.0 g/dL
• White blood cell counts below 3.5X10\^9/L.
• Granulocytes below 1.5X10\^9/L.
• Have Platelets below 100 X 10\^9/L
• Abnormal renal function with creatinine above 1.5X the upper limit of normal (ULN)
• Abnormal liver function tests with bilirubin above 1.5X the ULN, AST and ALT above 2.5 X ULN.
• Patients with active cardiovascular disease under continuous treatment
• Patients with associated malignancy currently receiving chemotherapy and/or radiation.
• Female adult patients that are pregnant, nursing or plan to nurse during and up to 12 months of treatment period.
• Subjects receiving another investigational drug.

Sponsors & Collaborators

• Efranat Ltd.: lead

MeSH Terms

Conditions

Recurrent respiratory papillomatosis

Central Study Contacts

Myriam Golembo, PhD

CONTACT

972-8-9724972; myriam.golembo@efranat.com

Uri Yogev

CONTACT

972-8-9724972; uri.yogev@efranat.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 3, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Last Updated: August 3, 2016

Record last verified: 2016-08