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

April 16, 2018 updated by: Oshadi Drug Administration

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zrifin, Israel
        • Assaf-Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oshadi D and Oshadi R
Anti tumor agents
Anti tumor agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events and serious adverse events occurence
Time Frame: treatment end (day 60 or 90)
treatment end (day 60 or 90)

Secondary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy endpoint of this study is Overall Response Rate (ORR)
Time Frame: treatment end (day 60 or 90)
treatment end (day 60 or 90)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the duration of treatment to achieve response
Time Frame: 9 months
To estimate the duration of treatment needed to achieve response
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lior Heller, Prof., Assaf Harofeh Medical Center, Zrifin, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 18, 2018

Last Update Submitted That Met QC Criteria

April 16, 2018

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OS-BCC-P2-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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