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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

Phase 1
21 Years
Not Enrolling
Tumor, Cancer, Metastasis

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Trial Information

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

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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events, serious adverse events occurrence

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Avishai Sella, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assaf-Harofeh MC


Israel: Ministry of Health

Study ID:




Start Date:

January 2011

Completion Date:

May 2012

Related Keywords:

  • Tumor
  • Cancer
  • Metastasis
  • Tumor
  • cancer
  • metastasis
  • Neoplasm Metastasis