Cervical Intraepithelial NeoplasiaPhase 2NCT03143491
Study of SOR007 Ointment for Cervical Intraepithelial Neoplasia (CIN)
A Phase 2 study testing SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment in people with Cervical Intraepithelial Neoplasia, run by DFB Soria, LLC.
Trial summary
This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 1 Mar 2019
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Female adults ≥ 18 years of age;
- Presence of newly diagnosed (within 8 weeks prior to administration of SOR007), histologically confirmed CIN 2, CIN 2/3 or CIN 3;
- Candidate for observation, treatment, or removal of CIN;
- Satisfactory colposcopy (visualization of the entire squamocolumnar junction and margins of any visible lesions);
- Appropriate contraception throughout study period;
Who cannot join
- Pap smear and/or colposcopy suspicious for invasive disease;
- History of previous conization/LEEP;
- History of toxic shock syndrome;
- Known allergy or prior intolerance to paclitaxel;
- Immunodeficiency (including HIV/AIDS and immunosuppressive medication);
- Current, reported participation in another experimental, interventional protocol;
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- Active lower genital infection(s);
- Malignant disease at the time of inclusion, with the exclusion of basal cell carcinoma (BCC) or dermal carcinoma-in-situ;
- Concurrent treatment with cytotoxic, radiation, immune-stimulative, or immune-suppressive therapy, or with systemic corticosteroid dose of > 5 mg/d or prednisone (or its equivalent);
- Concomitant use of topical vaginal medications or products;
- Pregnant or lactating;
- Pregnancy planned within six (6) months following study drug application;
- Significant acute or chronic medical or psychiatric illness or other environmental or social factors that, in the opinion of the Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study
About this study
Official title: Phase 2a Dose-Rising, Safety, Tolerability, and Efficacy Study of Topical SOR007 for Cervical Intraepithelial Neoplasia (CIN)
This is a Phase 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN).
Read the detailed description
In this Phase 2, open-label, dose-rising study, subjects with high grade (CIN 2 or 3) CIN will receive once-weekly topical application of SOR007 ointment to the ectocervix for four weeks. Subjects will be enrolled in three dose-escalating cohorts of three subjects assigned consecutively to receive 0.15%, 1.0%, or 2.0% SOR007 ointment. At the final study visit (Visit 7) subjects will undergo an excision or punch biopsy to record the stage of CIN. PK samples will be obtained post-application on Day 0 at 1, 2, 4, 6, and 24 hours' post-application on Day 1. Additional PK samples will be collected at each visit. Plasma samples for PK analysis on Days 7, 14 and 21 will be collected prior to SOR007 application.
The Medical Monitor will review all available data prior to dose escalation. Dose-escalation of SOR007 will be determined by the Medical Monitor. This will be repeated for each escalated dose until all dose levels have been enrolled or a dose is determined unsafe. Safety will be assessed in an ongoing manner and formal safety reviews will be conducted twice for each cohort: after Day 14 and after Day 49 of the last subject in the cohort. If a safety or tolerability issue becomes apparent in a cohort, an additional three subjects will be enrolled at that dose level, for a maximum of six subjects in that cohort. If ≥ 1 safety or tolerability issue occurs in the additional 3 subjects, the prior dose-level will be determined to be the highest dose with an acceptable safety and tolerability profile. If no further safety and tolerability issues are identified in the expanded cohort, dose-escalation will continue.
Once the highest dose with an acceptable safety and tolerability profile has been determined by the Medical Monitor, PI, and Sponsor Medical Director, a further 3 subjects will be enrolled to that dose level in order to increase the subject numbers.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOR007 (Uncoated Nanoparticulate Paclitaxel) OintmentDrug
1 mL of SOR007 applied topically to the ectocervix once-weekly for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| SOR007 0.15% | Experimental | 1 mL of 0.15% SOR007 Ointment Receives: Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment |
| SOR007 1.0% | Experimental | 1 mL of 1.0% SOR007 Ointment Receives: Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment |
| SOR007 2.0% | Experimental | 1 mL of 2.0% SOR007 Ointment Receives: Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.
Measured: 49 days
Secondary outcomes (4)
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of SOR007
Plasma samples for pharmacokinetic (PK) analysis will be obtained on Day 0 at 1, 2, 4, and 6 hours post-application, at 24 hours' post-application (Day 1), and at each subsequent clinic visit (samples on Days 7, 14, and 21 will be obtained prior to dose application).
Measured: 49 days
Pharmacokinetics: Peak plasma concentration (Cmax) of SOR007
Plasma samples for pharmacokinetic (PK) analysis will be obtained on Day 0 at 1, 2, 4, and 6 hours post-application, at 24 hours' post-application (Day 1), and at each subsequent clinic visit (samples on Days 7, 14, and 21 will be obtained prior to dose application).
Measured: 49 days
Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of SOR007
Plasma samples for pharmacokinetic (PK) analysis will be obtained on Day 0 at 1, 2, 4, and 6 hours post-application, at 24 hours' post-application (Day 1), and at each subsequent clinic visit (samples on Days 7, 14, and 21 will be obtained prior to dose application).
Measured: 49 days
Regression of CIN
Colposcopic changes as defined by the modified Reid Colposcopic Index (RCI) and confirmed by biopsy histology
Measured: Baseline and 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start1 Oct 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Why it stopped: Study never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 2, open-label, dose-rising trial. Subjects will enroll in three dose-rising cohorts of three subjects each. he next dose level cohort will enroll upon a finding of safety and tolerability at the previous cohort's first safety review. If a safety or tolerability issue arises in the first three subjects of a cohort, an additional three subjects will be enrolled at the same dose level. If ≥ 1 of the same safety and tolerability issue recurs in the additional 3 subjects, the prior dose-level will be determined to be the highest dose with an acceptable safety and tolerability profile. If no further safety and tolerability issues are identified in the expanded cohort, dose-escalation will continue.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- DFB Soria, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Responsible party
- Sponsor
- Investigators
- Karen K McCune, MD, PhD, Principal investigator, University of California, San FranciscoLisa Rahangdale, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143491
- Sponsor's protocol ID
- SOR007-2017-02
- Status last verified
- Oct 2017
- First submitted
- 4 May 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Dose-Rising, Safety, Tolerability, and Efficacy Study of Topical SOR007 for Cervical Intraepithelial Neoplasia (CIN)
- ClinicalTrials.gov ID
- NCT03143491
- Acronym / sponsor ID
- SOR007-2017-02
- Conditions
- Cervical Intraepithelial Neoplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DFB Soria, LLCIndustry (pharma, biotech, devices)
- Collaborators
- US Biotest, Inc.
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 8 May 2017 (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 2, open-label, dose-rising study evaluating the safety, tolerability, and preliminary efficacy of three concentrations of SOR007 ointment (0.15%, 1.0%, and 2.0%) applied topically once per week for four weeks to the ectocervix of subjects with high grade cervical intraepithelial neoplasia (CIN).
Detailed description
In this Phase 2, open-label, dose-rising study, subjects with high grade (CIN 2 or 3) CIN will receive once-weekly topical application of SOR007 ointment to the ectocervix for four weeks. Subjects will be enrolled in three dose-escalating cohorts of three subjects assigned consecutively to receive 0.15%, 1.0%, or 2.0% SOR007 ointment. At the final study visit (Visit 7) subjects will undergo an excision or punch biopsy to record the stage of CIN. PK samples will be obtained post-application on Day 0 at 1, 2, 4, 6, and 24 hours' post-application on Day 1. Additional PK samples will be collected at each visit. Plasma samples for PK analysis on Days 7, 14 and 21 will be collected prior to SOR007 application.
The Medical Monitor will review all available data prior to dose escalation. Dose-escalation of SOR007 will be determined by the Medical Monitor. This will be repeated for each escalated dose until all dose levels have been enrolled or a dose is determined unsafe. Safety will be assessed in an ongoing manner and formal safety reviews will be conducted twice for each cohort: after Day 14 and after Day 49 of the last subject in the cohort. If a safety or tolerability issue becomes apparent in a cohort, an additional three subjects will be enrolled at that dose level, for a maximum of six subjects in that cohort. If ≥ 1 safety or tolerability issue occurs in the additional 3 subjects, the prior dose-level will be determined to be the highest dose with an acceptable safety and tolerability profile. If no further safety and tolerability issues are identified in the expanded cohort, dose-escalation will continue.
Once the highest dose with an acceptable safety and tolerability profile has been determined by the Medical Monitor, PI, and Sponsor Medical Director, a further 3 subjects will be enrolled to that dose level in order to increase the subject numbers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 2, open-label, dose-rising trial. Subjects will enroll in three dose-rising cohorts of three subjects each. he next dose level cohort will enroll upon a finding of safety and tolerability at the previous cohort's first safety review. If a safety or tolerability issue arises in the first three subjects of a cohort, an additional three subjects will be enrolled at the same dose level. If ≥ 1 of the same safety and tolerability issue recurs in the additional 3 subjects, the prior dose-level will be determined to be the highest dose with an acceptable safety and tolerability profile. If no further safety and tolerability issues are identified in the expanded cohort, dose-escalation will continue.
| Arm | Type | Receives |
|---|---|---|
| SOR007 0.15% | Experimental | Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment1 mL of 0.15% SOR007 Ointment |
| SOR007 1.0% | Experimental | Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment1 mL of 1.0% SOR007 Ointment |
| SOR007 2.0% | Experimental | Drug: SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment1 mL of 2.0% SOR007 Ointment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent;
- Female adults ≥ 18 years of age;
- Presence of newly diagnosed (within 8 weeks prior to administration of SOR007), histologically confirmed CIN 2, CIN 2/3 or CIN 3;
- Candidate for observation, treatment, or removal of CIN;
- Satisfactory colposcopy (visualization of the entire squamocolumnar junction and margins of any visible lesions);
Key exclusion criteria (13 listed)
- Pap smear and/or colposcopy suspicious for invasive disease;
- History of previous conization/LEEP;
- History of toxic shock syndrome;
- Known allergy or prior intolerance to paclitaxel;
- Immunodeficiency (including HIV/AIDS and immunosuppressive medication);
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 |
|---|---|---|
| SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment1 mL of SOR007 applied topically to the ectocervix once-weekly for four weeks. | Drug | SOR007 0.15%, SOR007 1.0%, SOR007 2.0% |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 49 days
Treatment emergent adverse events will include all reported adverse events, laboratory assessments, physical examination findings, and vital signs.
4 secondary outcomes
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of SOR007
Time frame: 49 days
Pharmacokinetics: Peak plasma concentration (Cmax) of SOR007
Time frame: 49 days
Pharmacokinetics: Time at which peak plasma concentration is observed (Tmax) of SOR007
Time frame: 49 days
Regression of CIN
Time frame: Baseline and 49 days
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 18 Oct 2017.
- 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.
Karen K McCune, MD, PhD principal investigator
University of California, San Francisco
Lisa Rahangdale, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment in people with Cervical Intraepithelial Neoplasia, run by DFB Soria, LLC.
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 13 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 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Incidence of treatment emergent adverse events (time frame: 49 days). 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 Oct 2017.