Clinical trial NCT02134990: Oshadi D and Oshadi R in Combination With Docetaxel, as 2nd Line Therapy for Metastatic Non Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Docetaxel
Lead sponsor: Oshadi Drug Administration
Sponsor class: INDUSTRY
First posted: 2014-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 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.

Primary outcomes:
measure: overall survival time
timeFrame: 12 months
Secondary outcomes:
measure: Adverse events and serious adverse events occurence
timeFrame: One month following treatment initiation
measure: Patient report outcome
timeFrame: 12 months
Other outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 12 months
measure: Duration of Response (DoR);
timeFrame: 12 months
measure: Change in tumor size
timeFrame: 12 weeks
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Hovav Nehushtan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: