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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oshadi Drug Administration
ClinicalTrials.gov Identifier:
NCT01201018
First received: September 12, 2010
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Oshadi Drug Administration:

Primary Outcome Measures:
  • Adverse events, serious adverse events occurrence [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201018

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

No publications provided

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

Keywords provided by Oshadi Drug Administration:
Tumor
cancer
metastasis

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014