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

BCC Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02007317
• Other study ID #: OS-BCC-P2-01
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2013
• Last updated: April 16, 2018
• Start date: November 2013
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: Oshadi Drug Administration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• BCC
• Carcinoma, Basal Cell

Intervention

Drug:
• Oshadi D & Oshadi R
Anti tumor agents

Locations

Country	Name	City	State
Israel	Assaf-Harofeh Medical Center	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Oshadi Drug Administration

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To estimate the duration of treatment to achieve response	To estimate the duration of treatment needed to achieve response	9 months
Primary	Adverse events and serious adverse events occurence		treatment end (day 60 or 90)
Secondary	The primary efficacy endpoint of this study is Overall Response Rate (ORR)		treatment end (day 60 or 90)