Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment
Primary Purpose
Tumor, Cancer, Metastasis
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Oshadi D, Oshadi R
Sponsored by
About this trial
This is an interventional treatment trial for Tumor focused on measuring Tumor, cancer, metastasis
Eligibility 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.
Sites / Locations
- Assaf-Harofeh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oshadi DR
Arm Description
Outcomes
Primary Outcome Measures
Adverse events, serious adverse events occurrence
Secondary Outcome Measures
Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used.
Full Information
NCT ID
NCT01201018
First Posted
September 12, 2010
Last Updated
June 20, 2012
Sponsor
Oshadi Drug Administration
1. Study Identification
Unique Protocol Identification Number
NCT01201018
Brief Title
Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oshadi Drug Administration
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor, Cancer, Metastasis
Keywords
Tumor, cancer, metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oshadi DR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oshadi D, Oshadi R
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Adverse events, serious adverse events occurrence
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avishai Sella, Prof.
Organizational Affiliation
Assaf-Harofeh MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zrifin Beer-Yaakov
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment
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