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NCT06630416 · ClinicalTrials.gov registry record · Phase 2
Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothelial Bladder Cancer and Other Solid Tumors
A Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Bladder Urothelial Carcinoma, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
- 2
- Study locations
NCT06630416: Recruiting Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Bladder Urothelial Carcinoma, sponsored by Northwestern University.
NCT06630416 is a Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Bladder Urothelial Carcinoma that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 64 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06630416, a Phase 2 study of Metastatic Malignant Solid Neoplasm and Metastatic Bladder Urothelial Carcinoma, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial tests how well pemetrexed works in treating patients with urothelial bladder cancer and other solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) with mutations that result in a loss of function in the MLL4-protein/KMT2D-gene or UTX-protein/KDM6A-gene or MTAP enzyme. Loss of function due to a genetic mutation means a gene's activity may be reduced or eliminated. Mutations that result in a loss of function in the MLL4-protein or KMT2D-gene are found in 9.96% of all cancers including bladder carcinoma patients, esophageal squamous cell carcinoma and esophageal adenocarcinoma patients. In addition, mutations that result in a loss of function in the UTX-protein or KDM6A-gene are found in approximately 5% of all tumors, including bladder cancers, endometrial cancer, and esophagogastric cancer amongst many other tumor types. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Giving pemetrexed may increase response in patients with metastatic urothelial bladder cancer and other solid tumors with the loss of function in the MLL4-protein/KMT2D-gene or UTX-protein/KDM6A-gene or MTAP enzyme.
Primary Outcome
ORR is defined as the proportion of treated patients who experience an objective response (complete response \[CR\] or partial response \[PR\]). The date of first response for either CR or PR will be used to calculate ORR. Will be measured every 9 weeks +/- 10 days according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR and PR need to be confirmed by a subsequent scan. Will compute two-sided 90% confidence intervals (CIs) for ORR using the exact binomial method. T
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Pemetrexed
Study Locations (2)
Illinois
- Northwestern University - Chicago
- Northwestern Medicine Orland Park - Orland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2024-11-27 |
| Est. Completion | 2030-05-10 |
| Phase | Phase 2 |
What NCT06630416 shows while recruiting
NCT06630416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (69% lower).
The record links to 3 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT06630416 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06630416 about?
NCT06630416 is a clinical study titled "Pemetrexed Response in Relation to Tumor Alterations of Gene Status for the Treatment of Patients With Metastatic Urothelial Bladder Cancer and Other Solid Tumors". This phase II trial tests how well pemetrexed works in treating patients with urothelial bladder cancer and other solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic) with mutations that result in a loss of function in the MLL4-protein/K...
What is the current status of trial NCT06630416?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2024-11-27. Estimated completion is 2030-05-10.
What conditions does trial NCT06630416 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Bladder Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT06630416?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT06630416?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06630416 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06630416's enrollment target sits among peer trials
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