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

NCT02134990 | Unknown Phase 2

• 1 other identifier: OS-LC-P2a-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Carcinoma, Non-Small-Cell Lung; Docetaxel

Outcome Measures

Primary Outcomes (1)

• overall survival time

  overall survival of the patient

  12 months

Secondary Outcomes (2)

• Adverse events and serious adverse events occurence

  One month following treatment initiation

• Patient report outcome

  12 months

Other Outcomes (3)

• Progression Free Survival (PFS)

  12 months

• Duration of Response (DoR);

  12 months

• Change in tumor size

  12 weeks

Study Arms (1)

Oshadi D and Oshadi R with Docetaxel

EXPERIMENTAL

Oshadi D and Oshadi R anti cancer agents with Docetaxol chemotherapy

Drug: Oshadi D and Oshadi R; Drug: Docetaxel

Interventions

Oshadi D and Oshadi R DRUG

Anti cancer agents

Oshadi D and Oshadi R with Docetaxel

Docetaxel DRUG

Chemotheraphy

Also known as: Taxoter

Oshadi D and Oshadi R with Docetaxel

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oshadi Drug Administration: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Hovav Nehushtan, Prof.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Levy, Dr.

CONTACT

+972-52-2824966; hanna@oshadi-da.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

IL (1)