Alvopem® (Pemetrexed) Safety Assessment

NCT04843007 | Completed Results

• 1 other identifier: ALVOPEM.NA.AK.95 (IV)
• Study Type: observational
• Target: 199
• Locations: 0 countries
• Sites: N/A

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 adverse events (AEs).

Conditions

Non Small Cell Lung Cancer; Malignant Pleural Mesothelioma

Keywords

NSCLC; Observational study; pemetrexed; PMS; Safety

Outcome Measures

Primary Outcomes (1)

• Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE))

  In this study, number of participants who experienced at least one adverse event (AE) or one serious adverse event (SAE) were assessed. The intensity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and terminology for AEs was chosen according to the Medical Dictionary for Regulatory Activities (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 system organ class and preferred term of AEs and SAEs. Moreover, causality assessment was done based on the World health organization-Uppsala Monitoring Centre (WHO-UMC) system.

  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

Study Arms (1)

NanoAlvand Pemetrexed

500 mg/m\^2 pemetrexed, intravenous (IV) infusion

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2

Also known as: Alvopem®

NanoAlvand Pemetrexed

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer and malignant pleural mesothelioma were included in the study.

Sponsors & Collaborators

• NanoAlvand: lead

Related Publications (1)

• Seifi S, Salimi B, Monfared ZE, Sabahi C, Kafi H, Khosravi A. Alvopem(R) (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance. J Pharm Policy Pract. 2023 Jan 25;16(1):16. doi: 10.1186/s40545-023-00524-5.

  PMID: 36698207 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Mesothelioma, Malignant

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Pleural Neoplasms

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Dr. Hamidreza kafi
• Organization: NanoAlvand

Kafi.h@orchidpharmed.com

9129232594

Study Officials

• Adnan Khosravi, Assoc. Prof.

  National Research Institute of Tuberculosis and Lung Disease (NRITLD)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 13, 2021
• Study Start: March 15, 2016
• Primary Completion: January 22, 2020
• Study Completion: January 22, 2020
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-08