TumorPhase 1NCT01201018
Evaluation of the Safety and Efficacy of Oshadi D and Oshadi R for Cancer Treatment
A Phase 1 study testing Oshadi D, Oshadi R in people with Tumor and Cancer, run by Oshadi Drug Administration at 1 site in Israel.
Trial summary
The study will be non randomized, open label, dose rising study in cancer patients. Cancer treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be administered orally. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tumor, Cancer, Metastasis
- What is being tested?
- Oshadi D, Oshadi R
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to May 2012
- Phase
- Phase 1
- 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
- Histologically/ cytological proven solid tumor that is metastatic.
- Age > 21 years old.
- ECOG Performance status < 2.
- Documented progressive metastatic disease according to RECIST criteria.
- At least one lesion not within prior radiation field that is measurable per RECIST.
- Primary tumor must have been resected.
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- Four weeks must elapse from prior therapy.
- Patient has recovered to CTCAE < Grade 1 from toxicities related to previous treatment (except non-clinically significant AEs).
- Patient must have adequate organ function.
- 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.
- Life expectancy > 6 months.
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.
- Current or history of hematologic malignancies.
- Patient with positive HIV serology at screening.
- Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- Radiation therapy < 4 weeks prior to screening.
- Patient has received any other type of investigational agent < 4 weeks prior to screening.
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- Metastatic brain or meningeal disease.
- Patient has prothrombin time/International Normalization Ration (PT/INR) or partial thromboplastin time (PTT) test results > 1.3 UNL.
- Significant swallowing disorders.
- Small bowel surgery.
- Pelvic or abdominal radiation.
- Pre-existing mal absorption syndrome, irritable bowel syndrome or other clinical situation which could affect oral absorption.
- Evidence of concurrent (< 5 years) second malignancy other than basal cell carcinoma of the skin or cervical carcinoma in situ.
- 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 for Cancer Treatment - A Phase I Study
The study will be non randomized, open label, dose rising study in cancer patients. Cancer treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be administered orally.
The study will include two sessions:
- A single dose period to evaluate acute toxicity of each drug
- Consecutive multiple increment dose escalation period of both drugs to determine the long-term safety, and the anticancer activity.
- Conditions
- Tumor, Cancer, Metastasis
- Being tested
- Oshadi D, Oshadi R
- Keywords
- Tumor, cancer, metastasis
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oshadi D, Oshadi RDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Oshadi DR | Experimental | Not described 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, serious adverse events occurrence
Measured: 6 months
Secondary outcomes (1)
Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oshadi Drug Administration
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avishai Sella, Prof., Principal investigator, Assaf-Harofeh MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201018
- Sponsor's protocol ID
- OS-DRS-P1-01
- Status last verified
- Jun 2012
- First submitted
- 12 Sep 2010
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. 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 for Cancer Treatment - A Phase I Study
- ClinicalTrials.gov ID
- NCT01201018
- Acronym / sponsor ID
- OS-DRS-P1-01
- Conditions
- Tumor, Cancer, Metastasis
- Keywords
- Tumor, cancer, metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Oshadi Drug AdministrationIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Sep 2010 (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.
The study will be non randomized, open label, dose rising study in cancer patients. Cancer treatment is consisting of 2 different drugs: Oshadi D and Oshadi R that will be administered orally.
The study will include two sessions:
- A single dose period to evaluate acute toxicity of each drug
- Consecutive multiple increment dose escalation period of both drugs to determine the long-term safety, and the anticancer activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oshadi DR | Experimental | Drug: Oshadi D, Oshadi R |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically/ cytological proven solid tumor that is metastatic.
- Age > 21 years old.
- ECOG Performance status < 2.
- Documented progressive metastatic disease according to RECIST criteria.
- At least one lesion not within prior radiation field that is measurable per RECIST.
Key exclusion criteria (15 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.
- Current or history of hematologic malignancies.
- Patient with positive HIV serology at screening.
- Female patient who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- Radiation therapy < 4 weeks prior to screening.
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 ROral administration | Drug | Oshadi DR |
Primary outcome
Adverse events, serious adverse events occurrence
Time frame: 6 months
1 secondary outcome
Modified "Response Evaluation Criteria in Solid Tumors" (RECIST, Appendix 3) will be used.
Time frame: 6 months
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 21 Jun 2012.
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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.
Avishai Sella, Prof. principal investigator
Assaf-Harofeh MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oshadi D, Oshadi R in people with Tumor and Cancer, 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 13 inclusion and 15 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 21 Jun 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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, serious adverse events occurrence (time frame: 6 months). 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 21 Jun 2012.