A Trial With Metronomic Low-dose Treosulfan, Pioglitazone and Clarithromycin Versus Standard Treatment in NSCLC
NCT ID: NCT02852083
Last Updated: 2018-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
86 participants
INTERVENTIONAL
2016-01-31
2020-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC)
NCT06624059
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
NCT00160043
Efficacy, Safety and Pharmacokinetics Study of Antroquinonol to Treat NSCLC
NCT02047344
A Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Participants With Previously Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer
NCT04619797
A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
NCT05775289
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
86 patients with platin refractory Non-Small Cell Lung Cancer (NSCLC) will be treated either with metronomic low-dose treosulfan, pioglitazone and clarithromycin (experimental arm) or with nivolumab (squamous cell lung cancer and nonsquamous cell lung cancer).
Patients will undergo tumor assessments at baseline and every 6 weeks (approximately every two cycles) thereafter, until progression. Patients without progression after 36 weeks will undergo tumor assessments every 12 weeks.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A: Biomodulatory treatment
treosulfan 250 mg p.o. twice daily, pioglitazone 45 mg p.o. once daily, clarithromycin 250 mg p.o. twice daily until progression or no clinical benefit observed, whichever comes first.
Pioglitazone
Pioglitazone 25 mg once daily, p.o.
Treosulfan
Treosulfan 250 mg twice daily, p.o.
Clarithromycin
Clarithromycin 250 mg twice daily p.o.
B: Standard Treatment
Nivolumab, 3 mg per kilogram of body weight every 2 weeks until disease progression according to RECIST 1.1 or unacceptable toxicity
nivolumab
3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pioglitazone
Pioglitazone 25 mg once daily, p.o.
nivolumab
3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment)
Treosulfan
Treosulfan 250 mg twice daily, p.o.
Clarithromycin
Clarithromycin 250 mg twice daily p.o.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Ability to comply with protocol
* Age ≥ 18 years
* Measurable disease, as defined by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy ≥ 12 weeks
* Histologically or cytologically confirmed locally advanced or metastatic (i.e., Stage IIIB not eligible for definitive chemoradiotherapy, Stage IV, or recurrent) NSCLC (per the Union Internationale Contre le Cancer/American Joint Committee on Cancer \[UICC/AJCC\] staging system);
* Disease progression during or following treatment with a prior platinum containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum based adjuvant/neoadjuvant regimen
* No more than 2 cytotoxic chemotherapy regimens
* Patients that have progressed during or after treatment with EGFR Tyrosine Kinase Inhibitor (TKI) in first line, or are intolerant to treatment with erlotinib, gefitinib, or another EGFR TKI may be included.
* Patients that have progressed during or after , or intolerant to treatment with crizotinib or another ALK inhibitor
* The last dose of prior systemic anti-cancer therapy must have been administered ≥ 21 days prior to randomization (≥ 14 days for vinorelbine or other vinca alkaloids or gemcitabine.)
* The last dose of treatment with any investigational agent must have ended ≥ 28 days prior to randomization.
* Prior radiation therapy is allowed provided recovery from any toxic effects thereof and ≥ 7 days between the last fraction and randomization.
* Adequate hematologic and end organ function, defined by the following (max 14 days prior study treatment): Absolute Neutrophil Count (ANC) ≥ 1500 cells/μL (without granulocyte colonystimulating factor support within 2 weeks of sampling), White Blood Cell (WBC) counts \> 2,500/μL and \< 15,000/μL, lymphocyte count ≥ 500/μL, Platelet count ≥ 100,000/μL (without transfusion within 2 weeks of sampling), Hemoglobin ≥ 9.0 g/dL. Transfusion or erythropoietic treatment is allowed.
* Liver function tests meeting one of the following criteria: Aspartate Transaminase (AST) or Alanine Transaminase (ALT) ≤ 2.5 × ULN, with normal alkaline phosphatase or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase \> 2.5 × ULN; Serum bilirubin ≤ 1.0 × ULN. Patients with known Gilbert's disease must have serum bilirubin level ≤ 3 × ULN.
* Prothrombin Time - International Normalized Ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, without anticoagulants. Patients receiving therapeutic anticoagulation must be on a stable dose for at least 1 week prior to randomization.
* For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for 6 months after the last dose of the combined modularized treatment.
* Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia.
Exclusion Criteria
* History of intracranial hemorrhage
* Ongoing requirement for dexamethasone for CNS disease
* Stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1,Day 1
* Screening CNS imaging ≥ 4 weeks since completion of radiotherapy and ≥ 2 weeks since discontinuation of corticosteroids
* Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression that has not been clinically stable for ≥ 2 weeks prior to randomization
* Leptomeningeal disease
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
* Uncontrolled tumor-related pain: patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to enrolment. Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain should be considered for loco-regional therapy prior to enrolment.
* Hypercalcemia (Ca \> 1.5 mmol/L ionized calcium or Ca \> 12 mg/dL or corrected serum calcium \> ULN) or symptomatic hypercalcemia requiring continuous bisphosphonate therapy or denosumab. Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and without a history of clinically significant hypercalcemia are eligible.
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with curative outcome
* History of idiopathic pulmonary fibrosis (including pneumonitis), history of drug-induced pneumonitis
* Serum albumin \< 2.5 g/dL
* Patients with active hepatitis B or hepatitis C. Patients with past Hepatitis B Virus (HBV) infection or resolved HBV are eligible. Patients positive for Hepatitis C Virus (HCV) antibody are eligible only if Polymerase Chain Reaction (PCR) is negative for HCV Ribonucleic Acid (RNA).
* Significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease
* Significant cardiovascular disease, such as myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina.
* Known left ventricular ejection fraction (LVEF) \< 40%. Patients with known coronary artery disease, congestive heart failure not meeting the above criteria, or LVEF \< 50% must be on a stable medical regimen.
* Tuberculosis
* Severe infections within 4 weeks prior to randomization
* oral or intravenous antibiotics within 2 weeks prior to randomization
* Major surgical procedure within 4 weeks prior to randomization or expected need for a major surgical procedure during the course of the study other than for diagnosis
* Prior treatment with nivolumab
* Grade ≥ 2 peripheral neuropathy as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC AE) v4.0 criteria
* Patients undergoing dialysis or creatinine clearance \<30 mL per minute,defined according to Modification of Diet in Renal Disease Study Criteria (MDRD)
* Patients with uncontrolled hypertension (Respiratory rate continuously \> 140/90 mm Hg)
* Simultaneous treatment with another investigational agent or simultaneous anticancer treatment outside this trial
* Heart failure \> New York Heart Association (NYHA) 1, QT prolongation, ventricular arrhythmias, torsade de pointes
* Creatinine \> 1.5 mg/dL
* chronic hypopotassemia
* HIV infection requiring virostatic therapy
* past or current bladder cancer , patients with risk factors for bladder cancer (such as exposure to aromatic amines or heavy tobacco smokers), or macrohematuria of unknown origin
* Known gastrointestinal disorder, including malabsorption or active gastric ulcer, that might interfere with oral intake and absorption of study medication
* Autoimmune disease, symptomatic interstitial lung disease, systemic immunosuppression, prior therapy with T-cell costimulation or checkpoint targeted agent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Anticancer Fund
UNKNOWN
University Hospital Regensburg
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Albrecht Reichle
Prof. Dr.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Onkologische Gemeinschaftspraxis Dres. Wilke/ Wagner/Petzoldt
Fürth, Bavaria, Germany
Klinikum Kempten Oberallgäu
Immenstadt im Allgäu, Bavaria, Germany
MVZ am Klinikum GmbH
Passau, Bavaria, Germany
Universitätsklinikum Regensburg
Regensburg, Bavaria, Germany
Kliniken Nordoberpfalz AG, Klinikum
Weiden, Bavaria, Germany
MVZ Weiden GmbH
Weiden, Bavaria, Germany
St. Antonius-Hospital
Eschweiler, North Rhine-Westphalia, Germany
Klinik für Innere Medizin
Homburg/Saar, Saarland, Germany
Krankenhaus Martha-Maria
Halle, Saxony-Anhalt, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Gabriele Schulz
Role: primary
Karola Dorner
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ModuLung
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.