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

NCT02007317 | Completed Phase 2

• 1 other identifier: OS-BCC-P2-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

BCC

Outcome Measures

Primary Outcomes (1)

• Adverse events and serious adverse events occurence

  treatment end (day 60 or 90)

Secondary Outcomes (1)

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

  treatment end (day 60 or 90)

Other Outcomes (1)

• To estimate the duration of treatment to achieve response

  9 months

Study Arms (1)

Oshadi D and Oshadi R

EXPERIMENTAL

Anti tumor agents

Drug: Oshadi D & Oshadi R

Interventions

Oshadi D & Oshadi R DRUG

Anti tumor agents

Oshadi D and Oshadi R

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Oshadi Drug Administration: lead

Study Sites (1)

Assaf-Harofeh Medical Center

Zrifin, Israel

Location

Study Officials

• Lior Heller, Prof.

  Assaf Harofeh Medical Center, Zrifin, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 10, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 18, 2018

Record last verified: 2016-03

Locations

IL (1)