Trial · NCT05717621
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determination of the dose that is safe and tolerable (by the assessment of the rate of patients (%) experiencing at least one dose limiting toxicity (DLT)) as part of the determination of the recommended phase 2 dose (RP2D). | 28 days | The primary safety endpoint defined as rate of patients experiencing at least one DLT, will be identified by observing frequency, relation to IMP treatment and severity of specific AEs. |
| Primary | Determination of the dose that is effective (by the assessment of the rate of patients (%) with clinical complete or partial response (cCR/cPR) according to adapted RECIST criteria) as part of the determination of the recommended phase 2 dose (RP2D). | 16 months | The primary efficacy endpoint is defined as proportion (%) of patients who achieved clinical complete or partial response, as assessed by adapted RECIST criteria. (Clinical complete response (cCR) is defined as: Complete visual disappearance of the treated lesion(s) (i.e., 100% reduction in the sum of the longest diameter (SLD) among all treated lesions). Clinical partial response (cPR) is defined as: 30-99% reduction in the SLD among all treated lesions. |
| Secondary | Rate of patients (%) with pathological complete response (pCR) | 4 months | The efficacy will be further characterized by the rate of patients experiencing a pathological complete response of the treated lesion(s) in percent (%). |
| Secondary | Computer-based read-out of clinical response | 16 months | The efficacy will be further characterized by a computer-based read-out of manually annotated total surface area of the lesions (mm2/cm2), which will be followed by grading according to adapted RECIST criteria (cCR: 100% reduction in lesion size, cPR: 30-99% reduction in lesion size, SD: 1-29% reduction in lesion size, PD: ≥20% increase in lesion size). |
| Secondary | Molecular response | 4 months | The efficacy will be further characterized by the molecular response defined as reduction of combined p16INK4a/Ki-67-positive cells within the lesion (or in the region of the initial location of the lesion in case of complete lesion disappearance) and defined as decrease of DNMT1 protein expression in HPV-transformed cells determined by immunohistochemistry. |
| Secondary | Clearance of HPV infection in the reference lesion | 4 months | The efficacy will be further characterized by the analysis of the clearance of HPV infection in the reference lesion, defined as the absence of HPV DNA of the HR-HPV type(s) detected at baseline. |
| Secondary | Disease recurrence in patients | 16 months | The efficacy will be further characterized by determining the presence of recurrent lesions in treated patients. Disease recurrence is defined as the reappearance of lesions that were previously subject to complete clinical response. |
| Secondary | Onset of new lesions | 16 months | The efficacy will be further characterized by determining the presence of new lesions in treated patients. Onset of new lesions is defined as the appearance of new lesion(s) at a distinct vulvar site (i.e., a site different from the treated site(s)). |
| Secondary | Adherence to the treatment plan assessed by drug accountability and patient diaries | 4 months | The efficacy will be further characterized by the adherence of patients to the treatment plan. This will be assessed by IMP drug accountability as well as by self-reporting by patients according to a standardized study-specific questionnaire (paper-based patient diary). |
| Secondary | Further evaluation of safety and tolerability of the treatment by the assessment of adverse events (AEs) according to NCI CTCAE v5.0 | 16 months | The safety and tolerability of the treatment will be further assessed with the help of frequency tables with the number and percentage of patients who experienced the AE by treatment and total. Additionally, AEs will be summarized by seriousness of AE, relationship to the IMP, and grading for all NCI CTC categories (CTCAE v5.0). |
| Secondary | Evaluation of the quality of life (QoL) in patients treated with VTD-101 ointment with the help of the following corresponding endpoint: "VIN questionnaire" (QoL questionnaire modified and translated from [Lockhart et al. 2013]). | 4 months | QoL as assessed by means of 29 questions within the "VIN questionnaire" will be summarized using descriptive statistics and changes before and after treatment at respective time points by treatment and total. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT05717621/registered