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Trial record 2 of 4272 for:    "Carcinoma, Non-Small-Cell Lung"

Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02134990
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Oshadi Drug Administration

Brief Summary:

The study will be a prospective open-label single-center study in previously treated patients with Non Small Cell Lung Cancer (NSCLC). Treatment efficacy and safety of the combination of Oshadi D and Oshadi R with Docetaxel will be will be evaluated.

Patients will receive Docetaxel in combination with Oshadi D and Oshadi R. Patient will be evaluated throughout the study for safety and tolerance to multiple dose regimens of Oshadi D and Oshadi R.

CT or MRI imaging will be performed prior to treatment initiation and at the end of every 3 Docetaxel cycles (12 weeks). In case of disease progression, dose augmentation will be considered or subsequent therapy.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Oshadi D and Oshadi R Drug: Docetaxel Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIa, Open-Label, Single- Center Study to Assess the Activity of Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
Actual Study Start Date : June 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Oshadi D and Oshadi R with Docetaxel
Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy
Drug: Oshadi D and Oshadi R
Anti cancer agents

Drug: Docetaxel
Chemotheraphy
Other Name: Taxoter




Primary Outcome Measures :
  1. overall survival time [ Time Frame: 12 months ]
    overall survival of the patient


Secondary Outcome Measures :
  1. Adverse events and serious adverse events occurence [ Time Frame: One month following treatment initiation ]
    Adverse events and serious adverse events occurred during the study

  2. Patient report outcome [ Time Frame: 12 months ]
    To assess patients quality of life by QLC30 questionnaire


Other Outcome Measures:
  1. Progression Free Survival (PFS) [ Time Frame: 12 months ]
    time from treatment initiation to documentation of disease progression or death)

  2. Duration of Response (DoR); [ Time Frame: 12 months ]
    response duration to the drug

  3. Change in tumor size [ Time Frame: 12 weeks ]
    changes in tumor size



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Locally advanced or metastatic NSCLC (IIIB-IV)
  • Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
  • Man or woman 21 years and above
  • Adequate performance status (ECOG 0, and 1)
  • Patient must have adequate organ function
  • Written informed consent
  • Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
  • Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.

Exclusion Criteria:

  • Any treatment with investigational agent within 10 days prior to registration for protocol therapy.
  • Cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months prior to registration for protocol therapy.
  • Evidence of pulmonary embolism within 3 months prior to registration for protocol therapy.
  • Any history of hematologic malignancies.
  • Patient with known positive HIV serology at screening.
  • Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
  • Uncontrolled hypertension (>160/100 mm Hg despite optimal medical therapy).
  • Evidence of ongoing cardiac dysrhythmias of NCI CTCAE (Common Toxicity Criteria for Adverse Effects) Version 3.0 grade 2.
  • Patients in whom radiation or surgery is indicated
  • Significant swallowing disorders.
  • Small bowel surgery.
  • Suspicion of absorption disruption as a result of abdominal radiation
  • Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
  • Evidence of concurrent (< 5 years) second malignancy
  • Mental disorders.
  • Inability to give written informed consent.

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): NCT02134990


Contacts
Contact: Hanna Levy, Dr. +972-52-2824966 hanna@oshadi-da.com

Locations
Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel
Contact: Hanna Levy, Dr.    +972-52-2824966    hanna@oshadi-da.com   
Principal Investigator: Hovav Nehushtan, Prof.         
Sponsors and Collaborators
Oshadi Drug Administration
Investigators
Principal Investigator: Hovav Nehushtan, Prof. Hadassah Medical Center

Responsible Party: Oshadi Drug Administration
ClinicalTrials.gov Identifier: NCT02134990     History of Changes
Other Study ID Numbers: OS-LC-P2a-01
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Oshadi Drug Administration:
Carcinoma, Non-Small-Cell Lung
Docetaxel

Additional relevant MeSH terms:
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
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action