Clinical trial NCT04840004: Efficacy and Safety of PVT-1 Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Official title: Efficacy and Safety of PVT-1 Treatment in Patients With Advanced and Refractory Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Advanced Cancer
Refractory Cancer
Lead sponsor: PlusVitech S.L.
Sponsor class: OTHER
Collaborators: name: ECONiX Araştırma Analiz ve Danışmanlık A.Ş.
First posted: 2021-04-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lung cancer is one of the most common causes of cancer death worldwide. It is projected that the vast majority, approximately 80% -85% of all lung cancer diagnosis is Non-Small Cell Lung Cancer (NSCLC). Although there are significant improvements in the treatment of Lung Cancer in recent years, there is still an unmet medical need for a specific population which has advanced NSCLC and mostly is refractory to existing treatments.

In NSCLC the molecular profile is important to direct the treatment. Specifically, for cases with an EGFR+, ALK+, ROS1+ or PD1/PDL1+ molecular profile, targeted treatments are available. PVT-1 is a safe, orally administrable and well-tolerated drug directed against a specific therapeutic target of cancer cells what has demonstrated efficacy in NSCLC with a molecular profile EGFR-, ALK-, ROS1- and refractory to anti-PD1 / PDL1, in last line, which also represents the highest percentage of patients and with the highest chances of cancer progression with currently available treatments.


Eligibility criteria: Inclusion Criteria:

Female or male with age \> 18 years' old Personally signed and dated informed consent that indicating that the participant ( or a legal representative) has been informed of all aspects of the study Histologically or cytologically confirmed non-small cell lung cancer(NSCLC) NSCLC patients who are not suitable for surgery or radical radiotherapy or chemotherapy, or who have failed to or are intolerable for standard treatment in local advanced or metastatic NSCLC Diagnosis of a metastatic or locally advanced NSCLC with molecular profile EGFR (-), ALK (-) and ROS-1 (-), refractory to existing treatments Evidence of disease radiological measurable. Defined as at least one target lesion that can be accurately measured by imaging, at least one dimension as ≥20 mm with conventional computed tomography (CT), ≥10 mm with spiral CT scan (≥15mm for lymph node) Absence of untreated or symptomatic brain metastases or that requires the use of steroids.

Life expectancy of at least three months in the opinion of investigators ECOG performance status of 0-1 Time since last treatment received: 3 weeks from last QT cycle or 6 weeks if nitrosiureas, at least 2 weeks from the last RT session before the first administration of study drug (The administration of palliative radiotherapy for bone pain is allowed by any time)

Laboratory results required at the screening visit:

Neutrophils\> 1500 / mm3 Haemoglobin\> 9.0g / dl Platelets\> 100,000 / mm3 Total bilirubin \<1.5 times above the normal ranges Transaminases: AST, ALT \<2 times above the normal ranges, If there are liver metastases \<5 times above normal values.

Serum creatinine \<1.5 times above the normal ranges Female participants childbearing potential, must have a negative pregnancy test

Exclusion Criteria:

Pregnant female patients, Breastfeeding female patients Patients unable to meet the requirements (inclusion criteria) of the study Know hypersensitivity, history of allergic or anaphylactic reaction to the drug.

ECOG performance status ≥2 Any acute, chronic or psychiatric medical condition or laboratory abnormality that may increase the risk associated with the participation or PVT-1 administration in the study or may interfere with interpretation of the results, and in judgment of the investigator, would make the participant inappropriate for entry into this study.

Current history of alcoholism or drug addiction to DSM-IV criteria within 12 months prior to screening.

Patients with major organ dysfunctions and heart disease Patients with active tuberculosis Participation in any other clinical studies (phases I - IV) within 1 month or 5 half-lives, or participation in any clinical study of drugs that could present interaction within 1 year of screening visit.

Subjects who are directly involved in the conduct of the study, and their family members, site staff members supervised by study investigators.

Primary outcomes:
measure: Effect
timeFrame: 12 months
Secondary outcomes:
measure: Progression Free Survival and Overall Survival
timeFrame: 12 months
measure: High Dose
timeFrame: 12 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Baskent University
city: Ankara
country: Turkey
facility: Gazi University
city: Istanbul
country: Turkey
facility: Yeditepe University Hospital
city: Samsun
country: Turkey
facility: 19 May|s University
Study officials:
affiliation: Yeditepe University
name: Sahin Lacin
role: PRINCIPAL_INVESTIGATOR
References: