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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02134990
• Other study ID #: OS-LC-P2a-01
• Status: Recruiting
• Phase: Phase 2
• First received: May 7, 2014
• Last updated: April 16, 2018
• Start date: June 2014
• Est. completion date: June 2019

Study information

• Verified date: April 2018
• Source: Oshadi Drug Administration
• Contact: Hanna Levy, Dr.
• Phone: +972-52-2824966
• Email: hanna[@]oshadi-da.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Oshadi D and Oshadi R
Anti cancer agents
• Docetaxel
Chemotheraphy

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression Free Survival (PFS)	time from treatment initiation to documentation of disease progression or death)	12 months
Other	Duration of Response (DoR);	response duration to the drug	12 months
Other	Change in tumor size	changes in tumor size	12 weeks
Primary	overall survival time	overall survival of the patient	12 months
Secondary	Adverse events and serious adverse events occurence	Adverse events and serious adverse events occurred during the study	One month following treatment initiation
Secondary	Patient report outcome	To assess patients quality of life by QLC30 questionnaire	12 months