Alvopem® (Pemetrexed) Safety Assessment

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04843007
• Other study ID #: ALVOPEM.NA.AK.95 (IV)
• Status: Completed
• Start date: October 5, 2016
• Est. completion date: January 22, 2020

Study information

• Verified date: February 2021
• Source: NanoAlvand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: January 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Malignant Pleural Mesothelioma
• Mesothelioma
• Non Small Cell Lung Cancer

Intervention

Drug:
• Pemetrexed
Alvopem® was administered every 3 weeks with a dose of 500 mg/m2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NanoAlvand

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment	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.	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