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NCT03237390 · ClinicalTrials.gov registry record · Phase 1
Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 3
- Study locations
NCT03237390: Completed Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, sponsored by Mayo Clinic.
NCT03237390 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm that has completed, run by Mayo Clinic. The registered enrollment target is 43 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (76% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03237390, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and gemcitabine hydrochloride may work better in treating patients with solid tumors.
Primary Outcome
Defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 2 patients (out of 6).
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Ribociclib
- DRUG Gemcitabine Hydrochloride
- OTHER Pharmacological Study
Study Locations (3)
Arizona
- Mayo Clinic Hospital - Phoenix
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-01-04 |
| Est. Completion | 2022-05-17 |
| Phase | Phase 1 |
What the finished NCT03237390 record still lists
NCT03237390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (76% lower).
The record links to 2 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03237390 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03237390 about?
NCT03237390 is a clinical study titled "Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors". This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used ...
What is the current status of trial NCT03237390?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-01-04. Estimated completion is 2022-05-17.
What conditions does trial NCT03237390 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm.
What interventions are being tested in trial NCT03237390?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Ribociclib (DRUG), Gemcitabine Hydrochloride (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT03237390?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03237390 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03237390's enrollment target sits among peer trials
43 58th of 108 higher than 50 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced 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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