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NCT03009201 · ClinicalTrials.gov registry record · Phase 1
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03009201: Completed Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT03009201 is a Phase 1 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03009201, a Phase 1 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery (advanced). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as doxorubicin 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 doxorubicin hydrochloride may work better in treating patients with soft tissue sarcoma.
Primary Outcome
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03. All adverse events (AEs) will be tabulated and summarized by major organ category, grade, anticipation, and drug attribution. Serious adverse events (SAE) specific incidence and exact 95% confidence interval will be provided where appropriate.
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Doxorubicin Hydrochloride
- DRUG Ribociclib
- OTHER Pharmacological Study
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-03-10 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
What the finished NCT03009201 record still lists
NCT03009201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03009201 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03009201 about?
NCT03009201 is a clinical study titled "Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery". This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed by surgery (advanced). Ribociclib may stop the growth of tumor cells b...
What is the current status of trial NCT03009201?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-03-10. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03009201?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Doxorubicin Hydrochloride (DRUG), Ribociclib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT03009201?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03009201's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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