Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
199 participants
OBSERVATIONAL
2016-03-15
2020-01-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy
NCT01085630
Pemetrexed Disodium and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors
NCT01450384
A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma
NCT00668499
S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma
NCT00107419
Cabozantinib With Pemetrexed in Advanced Non-small Cell Lung Cancer, Urothelial Cancer and Malignant Mesothelioma
NCT04173338
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 serious adverse events (SAEs).
This study was single arm and the sample size of this study was 199 patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NanoAlvand Pemetrexed
500 mg/m\^2 pemetrexed, intravenous (IV) infusion
Pemetrexed
Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pemetrexed
Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria: There were no exclusion criteria for this study.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NanoAlvand
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adnan Khosravi, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
National Research Institute of Tuberculosis and Lung Disease (NRITLD)
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ALVOPEM.NA.AK.95 (IV)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.