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NCT04388852 · ClinicalTrials.gov registry record · Phase 1
DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers
A Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IVB Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT04388852: Active Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IVB Prostate Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04388852 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IVB Prostate Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 65 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04388852, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Stage IVB Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial studies the side effects and best dose of DS3201 when given together with and ipilimumab for the treatment of patients with prostate, urothelial, or renal cell cancer that has spread to other places in the body (metastatic). DS3201 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving DS3201 and ipilimumab may help to control the disease.
Primary Outcome
Adverse events will be graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 and tabulated by grade and ETOX status. All adverse events will be presented descriptively by event, grade, and attribution separately by dose level.
Conditions Studied
Interventions
- DRUG Valemetostat
- BIOLOGICAL Ipilimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-08-20 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04388852 still lists
NCT04388852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (68% lower).
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Valemetostat is the first listed.
NCT04388852 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04388852 about?
NCT04388852 is a clinical study titled "DS3201 and Ipilimumab for the Treatment of Metastatic Prostate, Urothelial and Renal Cell Cancers". This phase Ib trial studies the side effects and best dose of DS3201 when given together with and ipilimumab for the treatment of patients with prostate, urothelial, or renal cell cancer that has spread to other places in the body (metastatic). DS3201 may stop the growth of tumor cells by blocking s...
What is the current status of trial NCT04388852?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2020-08-20. Estimated completion is 2026-12-31.
What conditions does trial NCT04388852 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Stage IVB Prostate Cancer AJCC v8, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Metastatic Urothelial Carcinoma.
What interventions are being tested in trial NCT04388852?
The interventions under investigation include: Valemetostat (DRUG), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04388852?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04388852 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04388852's enrollment target sits among peer trials
65 41st of 92 higher than 52 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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