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

Oshadi Drug Administration1 site in 1 country20 target enrollmentJune 2014

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsOshadi D and Oshadi R Docetaxel

DrugsOshadi D and Oshadi R Docetaxel

Overview

Phase: Phase 2
Intervention: Oshadi D and Oshadi R
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Oshadi Drug Administration
Enrollment: 20
Locations: 1
Primary Endpoint: overall survival time
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

June 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oshadi Drug Administration

Responsible Party

Sponsor

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
•Patients in whom radiation or surgery is indicated
•Significant swallowing disorders.