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

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oshadi Drug Administration
• Treatments: Docetaxel

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.