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Phase Ia/Ib Study of RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261413
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : December 29, 2022
Sponsor:
Information provided by (Responsible Party):
RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.

Study Description
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Brief Summary:
This study designed as a multicenter, open label, two-step study to determine the optimum dose, pharmacokinetics, and the safety of RS-0139 in patients with a recurrent, locally advanced or metastatic non-small cell lung cancer (NSCLC). The research is planned as a two-step study (Phase Ia and phase Ib) and accelerated titration design (ATD) is used.

Condition or disease Intervention/treatment Phase
NSCLC Drug: RS-0139 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open Label, Two-step, Phase Ia/Ib Study of Tumor Targeted Prodrug RS-0139 in Patients With a Recurrent, Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : December 13, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RS-0139
There will be only RS-0139 arm in the study.
 Drug: RS-0139
RS-0139 will be administered for the indication of NSCLC.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 21 days for Phase Ia and 100 days for Phase Ib ]
    The maximum tolerated dose and the appropriate dose range of RS-0139 in recurrent, locally advanced or metastatic non-small cell lung cancer patients.


Secondary Outcome Measures :
  1. Dose-limiting toxicities [ Time Frame: 21 days for Phase Ia and 100 days for Phase Ib ]
    The incidence of dose-limiting toxicities occurring after each dose given to the patients

  2. Dose reductions or treatment interruptions [ Time Frame: 21 days for Phase Ia and 100 days for Phase Ib ]
    Dose reductions or treatment interruptions due to the possible adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have consented for the participation to the trial.
  • Patients of both sexes aged between 18-75 years.
  • Patients who have biopsy material prior to the participation in order to confirm the expression of integrin αvβ6 (for Phase Ib only).
  • Patients with stage IIIB or IV NSCLC and measurable disease by Response Evaluation Criteria in Solid Tumors and availability of at least one measurable tumor focus under RECIST v.1.1 criteria.
  • Patients with NSCLC who progressed after standard therapy options consisting of chemotherapy and/or immunotherapy.
  • Patients who completed the previous treatments 21 days before the first dose of the study drug.
  • Patients who have at least three months of life expectancy.
  • Patients with ECOG performance score 0-1

  • Patients with the following laboratory results:

    • Hemoglobin ≥10 mg/dl
    • Neutrophil ≥1,500/µL
    • Platelet ≥100,000/µL
    • Creatinine ≤1.5xULN or creatinine clearance ≥60mL/sec/1.73m2
    • Total bilirubin ≤ 1.5xULN
    • AST/ALT ≤2.5xULN; for patients who have confirmed liver metastasis: AST/ALT ≤5xULN.
    • Prothrombin time ≤1.5xULN (in case of no anticoagulant treatment).
    • Normal levels of serum magnesium and potassium concentrations

Exclusion Criteria:

  • Patients who have active and/or uncontrolled central nervous system (CNS) metastasis.
  • Patients who have pulmonary carcinosarcoma.
  • Patients who have presence of small cell lung cancer components.
  • Patients who have interstitial lung disease or interstitial pneumonia.
  • Patients who have cavitary lung lesions.
  • Patients who have serious cardiac dysfunction.
  • Patients who have insufficient target organ function.
  • Patients who experienced Grade 3 or higher toxicity related to the previous docetaxel treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who are enrolled in a clinical trial.
  • Patients who have serious medical conditions such as uncontrolled infection or untreated wound.
  • Patients who have bone marrow transplantation history.
  • Patients who have hypersensitivity to docetaxel and/or similar medicines.
  • Patients who, in the judgment of the Investigator, are likely to be non-compliant or unable to cooperate.
  • Patients who cannot be contacted in case of emergency.
  • Patients who are the investigator or sub-investigator, research assistant, pharmacist, study coordinator or other staff directly involved in conducting the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261413


Contacts
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Contact: Gulsah Nomak 00905333020180 gn@rsresearch.net
Contact: Sena Nomak 00905307606762 sn@rsresearch.net

Locations
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Turkey
Abdurrahman Yurtaslan Ankara Onkoloji Eğitim ve Araştırma Hastanesi Recruiting
Ankara, Turkey
Contact: Selim Şentürk       drselim32@gmail.com   
Koç University Hospital Phase I Center Recruiting
Istanbul, Turkey
Contact: Hakan S Orer       horer@ku.edu.tr   
Sponsors and Collaborators
RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.
More Information
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Responsible Party: RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.
ClinicalTrials.gov Identifier: NCT04261413    
Other Study ID Numbers: RS-001
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RS Arastirma Egitim Danismanlik Ilac Sanayi Ticaret A.S.:
lung cancer, chemotherapy, targeted therapy
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases