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

Oshadi Drug Administration

Status and phase

Unknown

Phase 2

Conditions

Carcinoma, Non-Small-Cell Lung

Treatments

Drug: Docetaxel

Drug: Oshadi D and Oshadi R

Study type

Interventional

Funder types

Industry

Identifiers

NCT02134990

OS-LC-P2a-01

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No 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.