Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01201018
• Date of registration: 12/09/2010
• Primary sponsor: Oshadi Drug Administration
• Public title: Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment
• Scientific title: A Single Center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment - A Phase I Study
• Date of first enrolment: January 2011
• Target sample size: 7
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01201018
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Israel

Contacts

• Name: Avishai Sella, Prof.
• Affiliation: Assaf-Harofeh MC

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cancer

Metastasis

Tumor

Intervention(s)

Drug: Oshadi D, Oshadi R

Primary Outcome(s)

Adverse events, serious adverse events occurrence [Time Frame: 6 months]

Secondary Outcome(s)

Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used. [Time Frame: 6 months]

Secondary ID(s)

OS-DRS-P1-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors