Metastatic Ovarian CancerPhase 1/2NCT03634150
Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer
A Phase 1/2 study testing Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties. in people with Metastatic Ovarian Cancer and Triple Negative Breast Cancer, run by Immune System Key Ltd at 1 site in Israel.
Trial summary
This is a Phase 1b, open-label, non-randomized, Dose Confirmation study. Subjects will be treated, once a week, with IV doses of Nerofe and low dose (20 mg/m2) Doxorubicin (6-8 hours from one another) in consecutive, 28-day cycles. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Metastatic Ovarian Cancer, Triple Negative Breast Cancer
- What is being tested?
- Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 6 Sep 2018to 21 Apr 2020
- Phase
- Phase 1/2
- 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 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females over18 years of age.
- Pathologically confirmed locally advanced and/or metastatic solid tumor, for which, in the judgment of the Principal Investigator, no standard curative therapy exists.
- Subjects must have 1 of the following solid tumor types: Ovarian cancer (up to 12 patients), or by Triple-negative breast cancer (up to 12 patients).
- Disease that is evaluable, or measurable on imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1 Appendix A), and where applicable is characterized by informative tumor marker(s).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2(Section 6.1.1.6) .
- Acceptable clinical laboratory values at screening, as indicated by:
Show all 12Show fewer
- Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 75,000/mm3; Total bilirubin ≤ 5 mg/dL. ASpartate aminoTransferase (SGOT) ≤ 2.5 × the Upper Limit of Normal; ALalanine aminoTransferase (SGPT) ≤ 2.5 × the Upper Limit of Normal; Serum creatinine ≤ 1.5 mg/dL or a measured creatinine clearance higher than 60 mL/min; and Negative serum Beta human chorionic gonadotropin test in women of childbearing potential (defined as women ≤ 50 years of age or history of amenorrhea for ≤ 12 months prior to study entry).
- Patients with hepatic metastasis are eligible to enroll, provided that the following criteria are met at Screening:
- Total bilirubin ≤ 5 mg/dL; ASpartate aminoTransferase and ALalanine aminoTransferase are each ≤ 5 × the Upper Limit of Normal;
- Willing and able to provide written Informed Consent and comply with the requirements of the study.
- Tumor tissue, taken from either an archival sample or a fresh biopsy, must be available for staining for T1/ST2 receptor, and must be ST2 positive.
- Subject has not been previously treated with Doxorubicin or total accumulated dose has never exceeded 240 mg/m2.
Who cannot join
- Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy (unless dose has been stable for 1 month prior to Baseline and remains stable during the trial), immunosuppressive therapy, corticosteroids > 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug.
- Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 1, as determined by NCI CTCAE v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).
- Receipt of >3 prior regimens of cytotoxic chemotherapy, including any use in the neo-adjuvant, adjuvant, and/or metastatic settings ,Unless more than 1 year elapsed since the Neo-adjuvant treatment was completed
- Receipt of Blood Transfusion during 2 weeks prior to Baseline
- Life expectancy <12 weeks.
- Major surgery or radiation therapy within 28 days prior to initiation of study drug,
Show all 24Show fewer
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome-related illness.
- Patients with history of brain metastasis
- Known active hepatitis B or C or other active liver disease (other than malignancy).
- Severe liver dysfunction (Child-Pugh Class B or C) and
- Patients with a history of esophageal bleeding have varices that have been sclerosed or banded and no bleeding episodes have occurred during the prior 6 months.
- Active infection requiring systemic therapy.
- Insulin-requiring diabetes mellitus will not be included if, according to the investigator, not stable, during the last 6 months.
- History of any of the following within 12 months prior to initiation of study drug:
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), unstable angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism (within the last 6 months). Left Ventricular Ejection Fraction <50% .
- Uncontrolled arterial hypertension, or anti-hypertensive drugs whose type or dose has been changed within 1 months prior to screening or whose dose is anticipated to change within cycle 1.
- Risk of syncope, in the judgment of the Principal Investigator, according to the patient's history of syncope.
- History of ongoing cardiac dysrhythmias requiring drug treatment
- Malignancies can be a reason for exclusion only if active during the last year or requiring any anti-tumor treatment. Skin non-melanomatous tumors and thyroid carcinomas - can be included. as well as, Previously treated malignancy within the past 2 years that the Principal Investigator deems to be at low risk for recurrence during the course of this trial.
- Use of any investigational agents within a minimum of 4 weeks or 5 half-lives of initiation of study drug.
- Pregnant or lactating female.
- Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Principal Investigator, are effective and adequate for that patient's circumstances while on study drug and for 3 months afterward.
- Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the patient inappropriate for entry into this study.
- Any known multiple allergy, or acute allergic reaction within the subject's medical History or General Practitioner's records.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Open-Label, Dose-Confirmation Study Evaluating the Safety, and Clinical Effects of Intravenously Administered Nerofe™ in Combination With Doxorubicin, In Subjects With Metastatic Ovarian Cancer and Triple Negative Breast Cancer
This is a Phase 1b, open-label, non-randomized, Dose Confirmation study. Subjects will be treated, once a week, with IV doses of Nerofe and low dose (20 mg/m2) Doxorubicin (6-8 hours from one another) in consecutive, 28-day cycles.
Read the detailed description
Subjects will be evaluated regularly for safety. Subjects will return for a follow-up visit 30-33 days after the last dosing of study drug. Subjects who tolerate the drug and who do not experience progressive disease, intolerable toxicity, or meet any of the other withdrawal criteria - may continue to receive Nerofe \& Doxorubicin for up to 5 cycles, at the discretion of the Principal Investigator. Throughout the trial, oversight will be provided by the Clinical Safety Committee (CSC).
- Being tested
- Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.
- Medical subject headings
- Ovarian Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.Biological
Also called Doxorubicin or Adriamycin is a registered chemotherapy, which belongs to the Anthracyclines. It slows or stops the growth of cancer cells.
Once weekly treatment, with IV doses of Nerofe (96mg\m2) and low dose (20 mg/m2) Doxorubicin 5 or 24 hours from one another) .
| Study group | Role | What they receive |
|---|---|---|
| Single arm Nerofe followed by Doxorubicin | Experimental | IV treatment of Nerofe 96 mg\m2 followed by IV Doxorubicin 10mg\m2 Once weekly Receives: Biological: Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary safety endpoint will be the Adverse Events (AE) reported during the combined treatment of Nerofe and low Dose doxorubicin , using the CTCAE score.
The Adverse Events (AE) reported during the combined treatment of Nerofe and low Dose doxorubicin, using the CTCAE score.
Measured: Safety data will be collected weekly during the subjects visits(Weeks 1-20), throughout the study and up to 1 year.
Assessing Change in tumor size from Baseline to End of study
Assessing Change in tumor size from Baseline to End of study under combined treatment of Nerofe and Low dose Doxorubicin in Ovarian cancer or triple negative breast cancer. Subject population will be evaluated using Response Evaluation Criteria in Solid Tumors, from Baseline, and every 2 cycles( 8 weeks), and last one- at the end of the study.
Measured: Imaging would be performed at Baseline and at the end of every 2 cycles(8 weeks), through the study completion, which is estimated to be after 6 months.
Assessing Change in Blood markers from Baseline to End of study
Assessing Change in tumor size from Baseline to End of study, under combined treatment of Nerofe and Low dose Doxorubicin, in Ovarian cancer or triple negative breast cancer. Subject population will be evaluated from Baseline, and every cycle( 28 days each cycle) until the end of the study.
Measured: Blood Markers would be measured at Baseline, and at the end of every cycle(28 Days in each cycle), through the study completion, which is estimated to be after 6 months.
Secondary outcomes (9)
Pharmacokinetic Profile
Pharmacokinetic Profile, including area under the curve.
Measured: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours
Pharmacokinetic Profile
Pharmacokinetic Profile, including maximum plasma concentration
Measured: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min ,1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacokinetic Profile
Pharmacokinetic Profile, including trough plasma concentration.
Measured: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacokinetic Profile
Pharmacokinetic Profile, including time to maximum plasma concentration.
Measured: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacokinetic Profile
Pharmacokinetic Profile, including plasma half-life.
Measured: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacodynamics profile
PharmacoDynamics profile, including changes in plasma levels of circulating cytokines
Measured: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle (28 Days in each cycle), through the study completion which is estimated to be after 6 months..
Pharmacodynamics profile
PharmacoDynamics profile, including changes in plasma levels of soluble T1/ST2 receptor
Measured: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle (28 Days in each cycle), through the study completion which is estimated to be after 6 months.
Pharmacodynamics profile
PharmacoDynamics profile, including changes in Peripheral blood mononuclear cells' T1/ST2 receptor expression
Measured: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle (28 Days in each cycle), through the study completion which is estimated to be after 6 months.
Pharmacodynamics profile
Immunogenicity of Nerofe, through the analysis of Plasma levels of circulating anti-Nerofe antibodies.
Measured: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle(28 Days in each cycle), through the study completion which is estimated to be after 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start6 Sep 2018
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Why it stopped: Patients were screened but not enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Ovarian CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental: IV Nerofe 96 mg\\m2 followed by IV Doxorubicin 10mg\\m2, once weekly
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune System Key Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoram Devary, phd, Study director, Immune System Key Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634150
- Sponsor's protocol ID
- ISK-N103
- Status last verified
- Oct 2021
- First submitted
- 20 Jun 2018
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stemmer SM, Benjaminov O, Silverman MH, Sandler U, Purim O, Sender N, Meir C, Oren-Apoteker P, Ohana J, Devary Y. A phase I clinical trial of dTCApFs, a derivative of a novel human hormone peptide, for the treatment of advanced/metastatic solid tumors. Mol Clin Oncol. 2018 Jan;8(1):22-29. doi: 10.3892/mco.2017.1505. Epub 2017 Nov 15.
PubMed 29423221
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Dose-Confirmation Study Evaluating the Safety, and Clinical Effects of Intravenously Administered Nerofe™ in Combination With Doxorubicin, In Subjects With Metastatic Ovarian Cancer and Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03634150
- Acronym / sponsor ID
- ISK-N103
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Patients were screened but not enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Immune System Key LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 16 Aug 2018 (actual)
- 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 is a Phase 1b, open-label, non-randomized, Dose Confirmation study. Subjects will be treated, once a week, with IV doses of Nerofe and low dose (20 mg/m2) Doxorubicin (6-8 hours from one another) in consecutive, 28-day cycles.
Detailed description
Subjects will be evaluated regularly for safety. Subjects will return for a follow-up visit 30-33 days after the last dosing of study drug. Subjects who tolerate the drug and who do not experience progressive disease, intolerable toxicity, or meet any of the other withdrawal criteria - may continue to receive Nerofe \& Doxorubicin for up to 5 cycles, at the discretion of the Principal Investigator. Throughout the trial, oversight will be provided by the Clinical Safety Committee (CSC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental: IV Nerofe 96 mg\m2 followed by IV Doxorubicin 10mg\m2, once weekly
| Arm | Type | Receives |
|---|---|---|
| Single arm Nerofe followed by Doxorubicin | Experimental | Biological: Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.IV treatment of Nerofe 96 mg\m2 followed by IV Doxorubicin 10mg\m2 Once weekly |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Females over18 years of age.
- Pathologically confirmed locally advanced and/or metastatic solid tumor, for which, in the judgment of the Principal Investigator, no standard curative therapy exists.
- Subjects must have 1 of the following solid tumor types: Ovarian cancer (up to 12 patients), or by Triple-negative breast cancer (up to 12 patients).
- Disease that is evaluable, or measurable on imaging by Response Evaluation Criteria in Solid Tumors (RECIST v1.1 Appendix A), and where applicable is characterized by informative tumor marker(s).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2(Section 6.1.1.6) .
Key exclusion criteria (24 listed)
- Any chemotherapy, immunomodulatory drug therapy, anti-neoplastic hormonal therapy (unless dose has been stable for 1 month prior to Baseline and remains stable during the trial), immunosuppressive therapy, corticosteroids > 20 mg/day prednisone or equivalent (unless administered to prevent contrast material reactions during radiographic procedures), or growth factor treatment (eg, erythropoietin) within 14 days prior to initiation of study drug.
- Presence of an acute toxicity of prior chemotherapy, with the exception of alopecia or peripheral neuropathy, that has not resolved to ≤ Grade 1, as determined by NCI CTCAE v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).
- Receipt of >3 prior regimens of cytotoxic chemotherapy, including any use in the neo-adjuvant, adjuvant, and/or metastatic settings ,Unless more than 1 year elapsed since the Neo-adjuvant treatment was completed
- Receipt of Blood Transfusion during 2 weeks prior to Baseline
- Life expectancy <12 weeks.
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 |
|---|---|---|
| Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties.Also: Doxorubicin or Adriamycin is a registered chemotherapy, which belongs to the Anthracyclines. It slows or stops the growth of cancer cells.Once weekly treatment, with IV doses of Nerofe (96mg\m2) and low dose (20 mg/m2) Doxorubicin 5 or 24 hours from one another) . | Biological | Single arm Nerofe followed by Doxorubicin |
Primary outcome
The primary safety endpoint will be the Adverse Events (AE) reported during the combined treatment of Nerofe and low Dose doxorubicin , using the CTCAE score.
Time frame: Safety data will be collected weekly during the subjects visits(Weeks 1-20), throughout the study and up to 1 year.
The Adverse Events (AE) reported during the combined treatment of Nerofe and low Dose doxorubicin, using the CTCAE score.
Assessing Change in tumor size from Baseline to End of study
Time frame: Imaging would be performed at Baseline and at the end of every 2 cycles(8 weeks), through the study completion, which is estimated to be after 6 months.
Assessing Change in tumor size from Baseline to End of study under combined treatment of Nerofe and Low dose Doxorubicin in Ovarian cancer or triple negative breast cancer. Subject population will be evaluated using Response Evaluation Criteria in Solid Tumors, from Baseline, and every 2 cycles( 8 weeks), and last one- at the end of the study.
Assessing Change in Blood markers from Baseline to End of study
Time frame: Blood Markers would be measured at Baseline, and at the end of every cycle(28 Days in each cycle), through the study completion, which is estimated to be after 6 months.
Assessing Change in tumor size from Baseline to End of study, under combined treatment of Nerofe and Low dose Doxorubicin, in Ovarian cancer or triple negative breast cancer. Subject population will be evaluated from Baseline, and every cycle( 28 days each cycle) until the end of the study.
9 secondary outcomes
Pharmacokinetic Profile
Time frame: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours
Pharmacokinetic Profile
Time frame: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min ,1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacokinetic Profile
Time frame: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacokinetic Profile
Time frame: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacokinetic Profile
Time frame: Pharmacokinetic sampling is planned once at Baseline. In Cycle 1(28 Days in each cycle), and Cycle 2 Day 1 visits: pre-dose and following the end of Nerofe infusion: 15 min, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, and 24 hours.
Pharmacodynamics profile
Time frame: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle (28 Days in each cycle), through the study completion which is estimated to be after 6 months..
Pharmacodynamics profile
Time frame: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle (28 Days in each cycle), through the study completion which is estimated to be after 6 months.
Pharmacodynamics profile
Time frame: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle (28 Days in each cycle), through the study completion which is estimated to be after 6 months.
Pharmacodynamics profile
Time frame: PharmacoDynamics sampling is planned at Baseline, at Day 1, 15, visits of every cycle(28 Days in each cycle), through the study completion which is estimated to be after 6 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Results publication: PubMed 29423221Stemmer SM, Benjaminov O, Silverman MH, Sandler U, Purim O, Sender N, Meir C, Oren-Apoteker P, Ohana J, Devary Y. A phase I clinical trial of dTCApFs, a derivative of a novel human hormone peptide, for the treatment of advanced/metastatic solid tumors. Mol Clin Oncol. 2018 Jan;8(1):22-29. doi: 10.3892/mco.2017.1505. Epub 2017 Nov 15.
- Individual participant dataSharing planned: No
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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.
Yoram Devary, phd study director
Immune System Key Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nerofe is a first in class derivative of a human hormon-peptide(TCApF), with Cancer suppressive properties. in people with Metastatic Ovarian Cancer and Triple Negative Breast Cancer, run by Immune System Key Ltd 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 12 inclusion and 24 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: withdrawn, as of the sponsor's last update on 26 Oct 2021. 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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
The primary safety endpoint will be the Adverse Events (AE) reported during the combined treatment of Nerofe and low Dose doxorubicin , using the CTCAE score. (time frame: Safety data will be collected weekly during the subjects visits(Weeks 1-20), throughout the study and up to 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03634150, which also lists 1 linked publication.
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 26 Oct 2021.