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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201018
• Other study ID #: OS-DRS-P1-01
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2010
• Last updated: June 20, 2012
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Oshadi Drug Administration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Cancer
• Metastasis
• Tumor

Intervention

Drug:
• Oshadi D, Oshadi R
Oral administration

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zrifin Beer-Yaakov

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, serious adverse events occurrence		6 months	Yes
Secondary	Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used.		6 months	No