Status:
COMPLETED
Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment
Lead Sponsor:
Oshadi Drug Administration
Conditions:
Tumor
Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
The study will be non randomized, open label, dose rising study in cancer patients. Cancer treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be administered orally. The st...
Eligibility Criteria
Inclusion
- Histologically/ cytological proven solid tumor that is metastatic.
- Age \> 21 years old.
- ECOG Performance status \< 2.
- Documented progressive metastatic disease according to RECIST criteria.
- At least one lesion not within prior radiation field that is measurable per RECIST.
- Primary tumor must have been resected.
- Four weeks must elapse from prior therapy.
- Patient has recovered to CTCAE \< Grade 1 from toxicities related to previous treatment (except non-clinically significant AEs).
- Patient must have adequate organ function.
- Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception during therapy and 3 months after the last dose of the study drugs.
- Female patients of childbearing potential must have a negative pregnancy test at screening.
- Patient must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
- Life expectancy \> 6 months.
Exclusion
- Uncontrolled Intercurrent illness or any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
- Current or history of hematologic malignancies.
- Patient with 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.
- Radiation therapy \< 4 weeks prior to screening.
- Patient has received any other type of investigational agent \< 4 weeks prior to screening.
- Metastatic brain or meningeal disease.
- Patient has prothrombin time/International Normalization Ration (PT/INR) or partial thromboplastin time (PTT) test results \> 1.3 UNL.
- Significant swallowing disorders.
- Small bowel surgery.
- Pelvic or 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 other than basal cell carcinoma of the skin or cervical carcinoma in situ.
- Mental disorders.
- Inability to give written informed consent.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01201018
Start Date
January 1 2011
End Date
May 1 2012
Last Update
June 21 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Assaf-Harofeh Medical Center
Zrifin Beer-Yaakov, Israel