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

Primary Purpose

BCC

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Oshadi D & Oshadi R

About this trial

This is an interventional treatment trial for BCC focused on measuring BCC

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Assaf-Harofeh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oshadi D and Oshadi R

Arm Description

Anti tumor agents

Outcomes

Primary Outcome Measures

Adverse events and serious adverse events occurence

Secondary Outcome Measures

The primary efficacy endpoint of this study is Overall Response Rate (ORR)

Full Information

NCT ID

NCT02007317

First Posted

December 4, 2013

Last Updated

April 16, 2018

Sponsor

Oshadi Drug Administration

1. Study Identification

Unique Protocol Identification Number

NCT02007317

Brief Title

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

Official Title

A Single Center, Open Label Study for Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R in Patients With Basal Cell Carcinoma (BCC) Prior to Tumor Excision- a Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oshadi Drug Administration

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

BCC

Keywords

BCC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oshadi D and Oshadi R

Arm Type

Experimental

Arm Description

Anti tumor agents

Intervention Type

Drug

Intervention Name(s)

Oshadi D & Oshadi R

Intervention Description

Anti tumor agents

Primary Outcome Measure Information:

Title

Adverse events and serious adverse events occurence

Time Frame

treatment end (day 60 or 90)

Secondary Outcome Measure Information:

Title

The primary efficacy endpoint of this study is Overall Response Rate (ORR)

Time Frame

treatment end (day 60 or 90)

Other Pre-specified Outcome Measures:

Title

To estimate the duration of treatment to achieve response

Description

To estimate the duration of treatment needed to achieve response

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lior Heller, Prof.

Organizational Affiliation

Assaf Harofeh Medical Center, Zrifin, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assaf-Harofeh Medical Center

City

Zrifin

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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