Trial Outcomes & Findings for Alvopem® (Pemetrexed) Safety Assessment (NCT NCT04843007)

Last Updated: 2024-10-23

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

199 participants

Primary outcome timeframe

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

Results posted on

2024-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	NanoAlvand Pemetrexed 500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Overall Study STARTED	199
Overall Study COMPLETED	198
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alvopem® (Pemetrexed) Safety Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NanoAlvand Pemetrexed n=198 Participants 500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Age, Continuous	61.11 years STANDARD_DEVIATION 11.36 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	130 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	198 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Weight	66.93 Kg STANDARD_DEVIATION 14.74 • n=5 Participants
Height	166.44 cm STANDARD_DEVIATION 9.88 • n=5 Participants
Body Surface Area (BSA)	1.75 m^2 STANDARD_DEVIATION 0.21 • n=5 Participants
Smokers	132 Participants n=5 Participants
Diagnosis NSCLC	186 Participants n=5 Participants
Diagnosis MPM	12 Participants n=5 Participants
Serum Creatinine (SCr)	1.02 mg/dL STANDARD_DEVIATION 0.22 • n=5 Participants
Bilirubin	0.46 mg/dL STANDARD_DEVIATION 0.30 • n=5 Participants
Blood Urea Nitrogen (BUN)	31.24 mg/dL STANDARD_DEVIATION 10.34 • n=5 Participants
Aspartate Aminotransferase (AST)	23.78 units/L STANDARD_DEVIATION 21.72 • n=5 Participants
Alanine Aminotransferase (ALT)	23.99 units/L STANDARD_DEVIATION 17.83 • n=5 Participants
Platelet (PLT)	324653 cells/μL STANDARD_DEVIATION 109183 • n=5 Participants
White Blood Cell (WBC)	10519 cells/μL STANDARD_DEVIATION 4920 • n=5 Participants
Neutrophil	7743 cells/μL STANDARD_DEVIATION 4541 • n=5 Participants
Hemoglobin (Hb)	12.68 g/dL STANDARD_DEVIATION 1.90 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: 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.

Outcome measures

Outcome measures
Measure	NanoAlvand Pemetrexed n=198 Participants 500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Safety Assessment Including Treatment-related Adverse Events (Number of Participants Who Experienced at Least One Adverse Event (AE) or One Serious Adverse Event (SAE))	190 Participants

Adverse Events

NanoAlvand Pemetrexed

Serious events: 50 serious events

Other events: 190 other events

Deaths: 28 deaths

Serious adverse events

Serious adverse events
Measure	NanoAlvand Pemetrexed n=198 participants at risk 500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Blood and lymphatic system disorders Anaemia	25.3% 50/198 • Three years and half

Other adverse events

Other adverse events
Measure	NanoAlvand Pemetrexed n=198 participants at risk 500 mg/m\^2 pemetrexed, IV infusion Pemetrexed: Alvopem® was administered every 3 weeks with a dose of 500 mg/m\^2
Blood and lymphatic system disorders Anaemia	89.4% 177/198 • Three years and half
Blood and lymphatic system disorders leukopenia	24.7% 49/198 • Three years and half
Blood and lymphatic system disorders neutropenia	28.8% 57/198 • Three years and half
Blood and lymphatic system disorders Thrombocytopenia	10.1% 20/198 • Three years and half
Investigations Alanine aminotransferase increased	10.1% 20/198 • Three years and half
Investigations Aspartate aminotransferase increased	6.1% 12/198 • Three years and half
Investigations Creatinine renal clearance decreased	24.2% 48/198 • Three years and half
Renal and urinary disorders Renal disorder	0.51% 1/198 • Three years and half
General disorders Drug intolerance	0.51% 1/198 • Three years and half

Additional Information

Dr. Hamidreza kafi

NanoAlvand

Phone: 9129232594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place