BCCPhase 2NCT02007317
Safety and Efficacy of Oshadi D and Oshadi R in Basal Cell Carcinoma Patients Prior to Tumor Excision a Phase 2 Study
A Phase 2 study testing Oshadi D & Oshadi R in people with BCC, run by Oshadi Drug Administration at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- BCC
- What is being tested?
- Oshadi D & Oshadi R
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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
- Being tested
- Oshadi D & Oshadi R
- Keywords
- BCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oshadi D & Oshadi RDrug
Anti tumor agents
| Study group | Role | What they receive |
|---|---|---|
| Oshadi D and Oshadi R | Experimental | Anti tumor agents Receives: Drug: Oshadi D & Oshadi R |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and serious adverse events occurence
Measured: treatment end (day 60 or 90)
Secondary outcomes (1)
The primary efficacy endpoint of this study is Overall Response Rate (ORR)
Measured: treatment end (day 60 or 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oshadi Drug Administration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lior Heller, Prof., Principal investigator, Assaf Harofeh Medical Center, Zrifin, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007317
- Sponsor's protocol ID
- OS-BCC-P2-01
- Status last verified
- Mar 2016
- First submitted
- 4 Dec 2013
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02007317
- Acronym / sponsor ID
- OS-BCC-P2-01
- Conditions
- BCC
- Keywords
- BCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Oshadi Drug AdministrationIndustry (pharma, biotech, devices)
- Study start
- Nov 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 10 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oshadi D and Oshadi R | Experimental | Drug: Oshadi D & Oshadi RAnti tumor agents |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oshadi D & Oshadi RAnti tumor agents | Drug | Oshadi D and Oshadi R |
Primary outcome
Adverse events and serious adverse events occurence
Time frame: treatment end (day 60 or 90)
1 secondary outcome
The primary efficacy endpoint of this study is Overall Response Rate (ORR)
Time frame: treatment end (day 60 or 90)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lior Heller, Prof. principal investigator
Assaf Harofeh Medical Center, Zrifin, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oshadi D & Oshadi R in people with BCC, run by Oshadi Drug Administration at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events occurence (time frame: treatment end (day 60 or 90)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.