Overview
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
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.