Alvopem® (Pemetrexed) Safety Assessment

Sponsor

NanoAlvand (Industry)

Overall Status

Completed

CT.gov ID

NCT04843007

Collaborator

(none)

199

Enrollment

39.6

Actual Duration (Months)

Study Details

Study Description

Brief Summary

The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma. No control groups were included in the study design.

The primary objective of this study was safety assessment, including the incidence of AEs.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer Malignant Pleural Mesothelioma	Drug: Pemetrexed

Detailed Description

The present study was a phase IV, post-marketing, observational study for safety evaluation of Alvopem® use in Iranian patients with non-small cell lung cancer and malignant pleural mesothelioma.

Data was gathered in one booklet, which had 6 different periods. The patients' information assessed after each injection, every 3 weeks. These booklets were completed by designated physicians.

The primary objective of this study was safety assessment, including the incidence and intensity of AEs and SAEs .

This study was single arm and the sample size of this study was 199 patients.

Study Design

Study Type:

Observational

Actual Enrollment :

199 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Alvopem® (Pemetrexed) Safety Assessment in Patients With Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma

Actual Study Start Date :

Oct 5, 2016

Actual Primary Completion Date :

Jan 22, 2020

Actual Study Completion Date :

Jan 22, 2020

Outcome Measures

Primary Outcome Measures

Safety assessment [This outcome was assessed throughout the study, up to 18 weeks (6 chemotherapy cycles). The duration of treatment was at the physicians' discretion based on the patient's condition]
In this safety assessment study, the incidence and intensity of all reported adverse events (AEs) and serious adverse events (SAEs) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events version 5.0 and terminology for AEs was chosen according to the MedDRA system organ class and preferred term. Also, intensity, seriousness, onset of AEs, and interventions for management of the adverse events were documented in the booklet. For each AE, data was summarized using incidence according to system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done and its results was reported by frequency and percentage.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: Patients diagnosed with non-small cell lung cancer and malignant pleural mesothelioma under chemotherapy regimens with Alvopem® were enrolled in the study.

Exclusion Criteria: There were no exclusion criteria for this study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

NanoAlvand

Investigators

Principal Investigator: Adnan Khosravi, Associate Professor, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences