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

This study has been completed.
Information provided by (Responsible Party):
Oshadi Drug Administration Identifier:
First received: September 12, 2010
Last updated: June 20, 2012
Last verified: June 2012

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 study will include two sessions:

  • A single dose period to evaluate acute toxicity of each drug
  • Consecutive multiple increment dose escalation period of both drugs to determine the long-term safety, and the anticancer activity.

Condition Intervention Phase
Tumor Cancer Metastasis Drug: Oshadi D, Oshadi R Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Further study details as provided by Oshadi Drug Administration:

Primary Outcome Measures:
  • Adverse events, serious adverse events occurrence [ Time Frame: 6 months ]

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

Enrollment: 7
Study Start Date: January 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oshadi DR Drug: Oshadi D, Oshadi R
Oral administration


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01201018

Assaf-Harofeh Medical Center
Zrifin Beer-Yaakov, Israel
Sponsors and Collaborators
Oshadi Drug Administration
Principal Investigator: Avishai Sella, Prof. Assaf-Harofeh MC
  More Information

Responsible Party: Oshadi Drug Administration Identifier: NCT01201018     History of Changes
Other Study ID Numbers: OS-DRS-P1-01
Study First Received: September 12, 2010
Last Updated: June 20, 2012

Keywords provided by Oshadi Drug Administration:

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes processed this record on August 18, 2017