Uterine Cervical NeoplasmsPhase 1NCT00989443
Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions
A Phase 1 study testing Cidofovir gel in people with Uterine Cervical Neoplasms and Cervix Intraepithelial Neoplasia, run by Mithra Pharmaceuticals at 1 site in Belgium.
Trial summary
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasms, Cervix Intraepithelial Neoplasia
- What is being tested?
- Cidofovir gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- May 2010to Sep 2010
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged between 18 and 50 years old
- volunteers
- informed consent signed
- cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
- no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)
Who cannot join
- pregnancy or breast feeding
- subtotal hysterectomy
- current or ancient renal impairment
- current immune disorder
- current use of drugs interfering with renal function
- current treatment for any cancer
Show all 11Show fewer
- current use of treatment interfering with immunity
- current use of anti-viral treatment
- current or recent participation to another experimental study during the last 3 months before the screening visit
- current vaginal application of drugs or cosmetics
- local or general condition incompatible with the experimental treatment in the opinion of the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Clinical Study to Evaluate the Tolerance and Safety of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesion(s) (CIN 2 and 3)
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.
This clinical study is aimed at :
- evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions;
- evaluating the pharmacokinetic (PK) profile of cidofovir after local application.
- Being tested
- Cidofovir gel
- Keywords
- Cervix Intraepithelial Neoplasia grades 2 and 3
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cidofovir gelDrug
topical gel applied once a week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cidofovir | Experimental | Not described Receives: Drug: Cidofovir gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events
Measured: weeks 1, 2, 3 and 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startMay 2010
- Primary completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmsStudies 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mithra Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michel Bossens, MD, PhD, Principal investigator, Erasme Hospital - Laboratoire de recherche en reproduction humaine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989443
- Sponsor's protocol ID
- MI-COL-CI01
- Other IDs
- EudraCT2009-012937-31
- Status last verified
- Oct 2010
- First submitted
- 2 Oct 2009
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Tolerance and Safety of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesion(s) (CIN 2 and 3)
- ClinicalTrials.gov ID
- NCT00989443
- Acronym / sponsor ID
- MI-COL-CI01
- Keywords
- Cervix Intraepithelial Neoplasia grades 2 and 3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Mithra PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Sep 2010 (actual)
- First posted
- 5 Oct 2009 (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.
Human Papilloma Virus (HPV) infections induce cervical intraepithelial neoplasia (CIN) of cervix. To reduce incidence of invasive tumor associated with high grade CIN lesions, the standard treatment is the conisation of cervix (surgical act). A local treatment with the antiviral and anti-proliferative cidofovir would preserve the cervix of young subjects and reduce obstetrical morbidity induced by the conisation.
This clinical study is aimed at :
- evaluating the tolerance and safety of a cidofovir gel directly applied on the cervix exhibiting high grade CIN lesions;
- evaluating the pharmacokinetic (PK) profile of cidofovir after local application.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cidofovir | Experimental | Drug: Cidofovir gel |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- women aged between 18 and 50 years old
- volunteers
- informed consent signed
- cervical lesion classified CIN 2 or 3, on a biopsy made during the 6 preceding weeks
- no sexual activity or use of effective mechanical, hormonal or intrauterine contraception (except hormonal vaginal ring)
Key exclusion criteria (11 listed)
- pregnancy or breast feeding
- subtotal hysterectomy
- current or ancient renal impairment
- current immune disorder
- current use of drugs interfering with renal function
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 |
|---|---|---|
| Cidofovir geltopical gel applied once a week for 3 weeks | Drug | Cidofovir |
Primary outcome
adverse events
Time frame: weeks 1, 2, 3 and 4
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 Oct 2010.
Related trials for Uterine Cervical Neoplasms
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 4
Ocular Assessments in Patients Treated With Tivdak® in Recurrent or Metastatic Cervical Cancer
Cervical Cancer
Recruiting
Use Misoprostol to Optimize Prevention of Cervical Cancer
Cervical Cancers
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
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.
Michel Bossens, MD, PhD principal investigator
Erasme Hospital - Laboratoire de recherche en reproduction humaine
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 Cidofovir gel in people with Uterine Cervical Neoplasms and Cervix Intraepithelial Neoplasia, run by Mithra Pharmaceuticals at 1 site in Belgium.
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 5 inclusion and 11 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 Oct 2010. 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 Belgium. 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 (time frame: weeks 1, 2, 3 and 4). 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 Oct 2010.