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

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

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.

Study Overview

• Status: Unknown
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: Oshadi D and Oshadi R; Drug: Docetaxel

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Recruiting
    • Hadassah Medical Center
    • Contact: Hanna Levy, Dr.; Phone Number: +972-52-2824966; Email: hanna@oshadi-da.com
    • Principal Investigator: Hovav Nehushtan, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Taxoter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival time	overall survival of the patient	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events and serious adverse events occurence	Adverse events and serious adverse events occurred during the study	One month following treatment initiation
Patient report outcome	To assess patients quality of life by QLC30 questionnaire	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	time from treatment initiation to documentation of disease progression or death)	12 months
Duration of Response (DoR);	response duration to the drug	12 months
Change in tumor size	changes in tumor size	12 weeks

Collaborators and Investigators

• Sponsor: Oshadi Drug Administration

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: May 7, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Docetaxel; Carcinoma, Non-Small-Cell Lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: OS-LC-P2a-01