Safety and Efficacy of Oshadi D and Oshadi R in Basal Cell Carcinoma Patients Prior to Tumor Excision a Phase 2 Study

NCT ID: NCT02007317

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-03-31

Brief Summary

This study is single-arm, none randomized, open label, two-dose-cohorts, single center clinical trial for evaluation of the safety and efficacy of Oshadi D and Oshadi R in patients with BCC. Patients will receive Oshadi D and Oshadi R for 60 -90 days until the planned surgical excision of the lesion.

Conditions

BCC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oshadi D and Oshadi R

Anti tumor agents

Group Type: EXPERIMENTAL

Oshadi D & Oshadi R

Intervention Type: DRUG

Anti tumor agents

Interventions

Oshadi D & Oshadi R

Anti tumor agents

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age > 21 years old with tissue confirmed diagnosis of local BCC.
• Patient is candidate for surgical excision of the BCC in few months.
• BCC lesion ≥10mm in its longest diameter.
• 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.

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.
• Other active cancer disease.
• Serum creatinine > 1.5 mg/dL for males and >1.4 mg/dL for females.
• Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
• Any acute cardiovascular event during the last 6 months prior to inclusion.
• Symptomatic congestive heart failure with ejection fraction < 30%.
• Patient has prothrombin time/International Normalization Ration (PT/INR) or partial thromboplastin time (PTT) test results > 1.3 UNL.
• Hemoglobin ≤ 11 g/dL
• Platelets < 150,000 per microliter
• White blood cell count<3,000 x109/L and/or absolute neutrophils count <1.5 x 109/L
• Significant swallowing disorders.
• History of small bowel surgery.
• Any history of pelvic or abdominal radiation.
• Pre-existing mal-absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
• Mental disorders.
• Inability to give written informed consent.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oshadi Drug Administration

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lior Heller, Prof.

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofeh Medical Center, Zrifin, Israel

Locations

Assaf-Harofeh Medical Center

Zrifin, , Israel

Countries

Israel

Other Identifiers

OS-BCC-P2-01

Identifier Type: -

Identifier Source: org_study_id