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NCT03473730 · ClinicalTrials.gov registry record · Early Phase 1
Daratumumab in Treating Patients with Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer
A Early Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT03473730: Completed Early Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT03473730 is a Early Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8 that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 17 participants, below the 203-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03473730, a Early Phase 1 study of Clear Cell Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Objectives: Primary: Safety and tolerability of therapy with daratumumab in a cohort of patients with metastatic renal cell carcinoma and a cohort of patients with muscle invasive bladder cancer. Secondary: 1A. To assess the proportion of patients who achieve pathological CR with daratumumab in patients with muscle invasive bladder cancer. 1B. To assess the objective response rate (ORR) to daratumumab in patients with metastatic renal cell carcinoma. 2\. To assess the progression free survival for patients with metastatic renal cell carcinoma receiving Daratumumab.
Primary Outcome
Adverse events will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Will be recorded for all patients, recording name, grade, start and end dates, attribution to study drug, and whether the event was alleviated or controlled with relevant appropriate care similar to Phase I trials. Adverse events, serious adverse events (SAEs), and toxicities (TOX) will be summarized by grade and attribution in descriptive tables and figures by cohort.
Conditions Studied
Interventions
- PROCEDURE Biopsy
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Daratumumab
- PROCEDURE Metastasectomy
- PROCEDURE Nephrectomy
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2025-01-27 |
| Phase | Early Phase 1 |
What the finished NCT03473730 record still lists
NCT03473730 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 203-participant average among 45 other Clear Cell Renal Cell Carcinoma trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with Clear Cell Renal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biopsy is the first listed.
NCT03473730 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03473730 about?
NCT03473730 is a clinical study titled "Daratumumab in Treating Patients with Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer". Objectives: Primary: Safety and tolerability of therapy with daratumumab in a cohort of patients with metastatic renal cell carcinoma and a cohort of patients with muscle invasive bladder cancer. Secondary: 1A. To assess the proportion of patients who achieve pathological CR with daratumumab in ...
What is the current status of trial NCT03473730?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 17 participants. The study started on 2018-05-29. Estimated completion is 2025-01-27.
What conditions does trial NCT03473730 study?
This clinical trial studies the following conditions: Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Bladder Urothelial Carcinoma, Metastatic Kidney Carcinoma, Malignant Urinary System Neoplasm.
What interventions are being tested in trial NCT03473730?
The interventions under investigation include: Biopsy (PROCEDURE), Laboratory Biomarker Analysis (OTHER), Daratumumab (BIOLOGICAL), Metastasectomy (PROCEDURE), Nephrectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03473730?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03473730 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 NCT03473730's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clear Cell Renal Cell Carcinoma 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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