Trial · NCT07034053
Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma
NCT07034053, Phase 1, Phase 2, Recruiting, Ekaterina Laukhtina
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma. Trials, record NCT07034053. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07034053
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma
- NCT number
- NCT07034053
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Ekaterina Laukhtina
- Conditions
- Advanced Urothelial Carcinoma, Metastatic Urothelial Cancer
- Interventions
- Clofarabine
- First posted
- 2025-06-24
- Last updated
- 2025-06-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determining the maximum tolerated dose (MTD) | From the start of study drug administration through the first 28 days of dosing (Cycle 1), based on the observed incidence of dose-limiting toxicity (DLT) and evaluation of maximum tolerated dose (MTD) | The objective of the dose selection phase is to determine the maximum tolerated dose (MTD) or confirm that the start dose level of clofarabine is safe. The MTD is defined as the highest dose at which the probability of toxicity remains below the target toxicity threshold. MTD estimation will be based on the observed dose-dependent incidence rate of dose-limiting toxicity (DLT) within the first 28 days of dosing (Cycle 1). Patients eligible for MTD evaluation include: * Those who completed Cycle 1 and took at least 80% of the required total dose of the study drug (protocol-defined dose reductions will not be considered noncompliance). * Those who discontinued during Cycle 1 due to a DLT. |
| Secondary | Objective response rate (ORR) | From the date of study treatment start until the date of the best documented objective response (for a maximum duration of 36 months). | Objective response rate (ORR) is defined as the percentage of patients whose best response is either a complete response (CR) or partial response (PR). Patients for whom best tumor response is not CR or PR, as well as patients without any efficacy assessment will be considered non-responders. According to RECIST v1.1, confirmation of PR and CR is not required considering the nature of the study and the protocol requirements. |
| Secondary | Duration of response (DOR) | From the date of the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (for a maximum duration of 36 months). | Duration of response (DOR) (for PR and CR) is defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR. The actual dates the tumor scans were performed will be used for this calculation. DOR for patients who have not progressed or died at the time of analysis will be censored at the date of their last tumor assessment. |
| Secondary | Progression-free survival (PFS) | From the date of study treatment start until the date of the first observed progression or date of death due to any cause, if death occurs before progression is documented (for a maximum duration of 36 months). | Progression-free survival (PFS) is defined as the time (days) from start of study treatment to date of first observed disease progression (investigator's radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. The actual date that the tumor scan was performed will be used for this calculation. If a tumor assessment is performed over more than one day (e.g. scans for chest and abdomen done on different days for the same evaluation), the earliest date will be used for the calculation of PFS. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation. |
| Secondary | Overall survival (OS) | From the date of study treatment start until the date of death due to any cause (for a maximum duration of 36 months). | Overall survival (OS) is defined as the time from start of study treatment to death due to any cause. Patients alive at the date of data cut-off for analysis will be censored at the last date known to be alive. If a patient is lost to follow-up before any assessment after assignment to treatment, this patient will be censored at 1 day. |
| Secondary | Safety and tolerability endpoints | Day 1 up to 90 days after last dose of study drug. | Individual listings of adverse events will be provided. Treatment-related adverse events evaluated using the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 5.0). Adverse events will be reported as absolute numbers (n) and relative frequencies (%). Visualization of the results will be presented with help of tables and diagrams. |
| Secondary | Area under the concentration-time curve (AUC) | Day 1 up to the date of the last dose of study drug. | The concentration-times courses of all analytes will be tabulated by dose level. |
| Secondary | Maximum serum concentration (Cmax) of Clofarabine | Day 1 up to the date of the last dose of study drug. | The concentration-times courses of all analytes will be tabulated by dose level. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07034053
GET https://conductscience.org/api/trials/v1/NCT07034053/registered