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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Tumor, Cancer, Metastasis

Intervention / Treatment
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* Drug: Oshadi D, Oshadi R


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oshadi DR<br> | Drug: Oshadi D, Oshadi R<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, serious adverse events occurrence |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Response Evaluation Criteria in Solid Tumors (RECIST, Appendix 3) will be used. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor, cancer, metastasis