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

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Oshadi D and Oshadi R

Docetaxel

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell Lung, Docetaxel

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hadassah Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oshadi D and Oshadi R with Docetaxel

Arm Description

Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy

Outcomes

Primary Outcome Measures

overall survival time

overall survival of the patient

Secondary Outcome Measures

Adverse events and serious adverse events occurence

Adverse events and serious adverse events occurred during the study

Patient report outcome

To assess patients quality of life by QLC30 questionnaire

Full Information

NCT ID

NCT02134990

First Posted

May 7, 2014

Last Updated

April 16, 2018

Sponsor

Oshadi Drug Administration

1. Study Identification

Unique Protocol Identification Number

NCT02134990

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 2014 (Actual)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oshadi Drug Administration

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung, Docetaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oshadi D and Oshadi R with Docetaxel

Arm Type

Experimental

Arm Description

Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy

Intervention Type

Drug

Intervention Name(s)

Oshadi D and Oshadi R

Intervention Description

Anti cancer agents

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxoter

Intervention Description

Chemotheraphy

Primary Outcome Measure Information:

Title

overall survival time

Description

overall survival of the patient

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Adverse events and serious adverse events occurence

Description

Adverse events and serious adverse events occurred during the study

Time Frame

One month following treatment initiation

Title

Patient report outcome

Description

To assess patients quality of life by QLC30 questionnaire

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Progression Free Survival (PFS)

Description

time from treatment initiation to documentation of disease progression or death)

Time Frame

12 months

Title

Duration of Response (DoR);

Description

response duration to the drug

Time Frame

12 months

Title

Change in tumor size

Description

changes in tumor size

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hanna Levy, Dr.

Phone

+972-52-2824966

hanna@oshadi-da.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hovav Nehushtan, Prof.

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hanna Levy, Dr.

Phone

+972-52-2824966

hanna@oshadi-da.com

First Name & Middle Initial & Last Name & Degree

Hovav Nehushtan, Prof.

12. IPD Sharing Statement

Learn more about this trial

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

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