- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04840004
Efficacy and Safety of PVT-1 Treatment in Patients With Advanced Non-Small Cell Lung Cancer
Efficacy and Safety of PVT-1 Treatment in Patients With Advanced and Refractory Non-Small Cell Lung Cancer
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sahin Lacin, MD, PhD
- Phone Number: +902124447000
- Email: sahin.lacin@yeditepe.edu.tr
Study Contact Backup
- Name: Guvenc Kockaya, MD, PhD
- Phone Number: +902124447000
- Email: guvenc.kockaya@yeditepe.edu.tr
Study Locations
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Adana, Turkey
- Recruiting
- Başkent University
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Ankara, Turkey
- Recruiting
- Gazi University
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Istanbul, Turkey
- Recruiting
- Yeditepe University Hospital
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Contact:
- Sahin Lacin, MD, PhD
- Email: sahin.lacin@yeditepe.edu.tr
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Contact:
- Guvenc Kockaya, MD, PhD
- Email: guvenc.kockaya@yeditepe.edu.tr
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Samsun, Turkey
- Recruiting
- 19 May|s University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: PVT-1
One arm study.
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Since there is no specific dose range is available for testing the anti-tumor effects of PVT-1 in clinical trials settings, in the present study the dose of PVT-1 will be up-titrated 250/160/160 mg to maximum 1000/640/640 mg as described in study methodology section.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect
Time Frame: 12 months
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The primary objective of this trial is to demonstrate the effect of high dose and long-term use of PVT-1 on tumor response.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival and Overall Survival
Time Frame: 12 months
|
Progression free survival (PFS) and overall survival (OS).
PFS will be defined as the time from the date of patients' registration to the date of the evidence of progressive disease, death due to any cause, or the last date the patient will be known to be progression-free or alive.
OS will be calculated from the date of patients' registration to the date of death from any cause or the last date the patient will be known to be alive.
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12 months
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High Dose
Time Frame: 12 months
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The evaluation of plasma concentration of high doses of PVT-1 treatment.
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sahin Lacin, Yeditepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLUSV_00
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Small Cell Lung Cancer
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WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
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National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
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Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
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National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
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Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
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Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
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