Alvopem® (Pemetrexed) Safety Assessment

An observational study of Non Small Cell Lung Cancer and Malignant Pleural Mesothelioma, run by NanoAlvand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Non Small Cell Lung Cancer, Malignant Pleural Mesothelioma
What is being tested?: Pemetrexed
Type of treatment: Injection or infusion
How many people: 199 participants
Where: No sites listed yet
Study dates: 15 Mar 2016to 22 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

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.

About this study

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

The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).

Read the 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 serious adverse events (SAEs).

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

Conditions: Non Small Cell Lung Cancer, Malignant Pleural Mesothelioma
Being tested: Pemetrexed
Keywords: NSCLC; Observational study; pemetrexed; PMS; Safety
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Mesothelioma, Malignant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04843007
Study group	Role	What they receive
NanoAlvand Pemetrexed		500 mg/m^2 pemetrexed, intravenous (IV) infusion Receives: Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201622 Jan 2020

First posted13 Apr 2021
Study start15 Mar 2016
Primary completion22 Jan 2020
Study completion22 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04843007
Sponsor's protocol ID: ALVOPEM.NA.AK.95 (IV)
Status last verified: Aug 2024
First submitted: 7 Apr 2021
Last updated: 23 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 36698207

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Non Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alvopem® (Pemetrexed) Safety Assessment in Patients With Non-small Cell Lung Cancer and Malignant Pleural Mesothelioma
ClinicalTrials.gov ID: NCT04843007
Acronym / sponsor ID: ALVOPEM.NA.AK.95 (IV)
Conditions: Non Small Cell Lung Cancer, Malignant Pleural Mesothelioma
Keywords: NSCLC; Observational study; pemetrexed; PMS; Safety
Study type: Observational
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: NanoAlvandIndustry (pharma, biotech, devices)
Study start: 15 Mar 2016 (actual)
Primary completion: 22 Jan 2020 (actual)
Study completion: 22 Jan 2020 (actual)
First posted: 13 Apr 2021 (actual)
Results: Posted 23 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study was safety assessment, including the incidence of adverse events (AEs).

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 serious adverse events (SAEs).

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
NanoAlvand Pemetrexed	–	Drug: Pemetrexed500 mg/m^2 pemetrexed, intravenous (IV) infusion

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with non-small cell lung cancer and malignant pleural mesothelioma were included in the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PemetrexedAlso: Alvopem®Alvopem® was administered every 3 weeks with a dose of 500 mg/m^2	Drug	NanoAlvand Pemetrexed

Primary outcome

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

Results and safety

Results posted to the registry on 23 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NanoAlvand Pemetrexed	199	198

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

Time frame: 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. Count of participants. Unit: Participants

Measure	NanoAlvand Pemetrexed n = 198
Value	190

Population analysed: The safety population is defined as all patients who received at least one dose of the study drug. In this study, a total of 199 patients with non-squamous non-Small cell lung cancer (NSCLC) or malignant pleural mesothelioma (MPM) were enrolled. However, one patient was excluded from the safety analysis due to the absence of a recorded diagnosis, resulting in a safety population of 198 individuals.

Adverse events

Time frame: Three years and half. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NanoAlvand Pemetrexed	50 of 198 (25.3%)	190 of 198 (96%)	28 of 198

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36698207Seifi 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.
Individual participant dataSharing planned: Undecided

Related trials for Non Small Cell Lung Cancer

Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
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Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 1
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RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adnan Khosravi, Assoc. Prof. principal investigator

National Research Institute of Tuberculosis and Lung Disease (NRITLD)

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer and Malignant Pleural Mesothelioma, run by NanoAlvand.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE)) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04843007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.