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NCT06835972 · ClinicalTrials.gov registry record · Phase 1
A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)
A Phase 1 study of Metastatic Renal Cell Carcinoma and Translocation Renal Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
- 8
- Study locations
NCT06835972: Recruiting Phase 1 study of Metastatic Renal Cell Carcinoma and Translocation Renal Cell Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT06835972 is a Phase 1 study of Metastatic Renal Cell Carcinoma and Translocation Renal Cell Carcinoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 43 participants, below the 142-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (70% lower). The trial reports 8 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06835972, a Phase 1 study of Metastatic Renal Cell Carcinoma and Translocation Renal Cell Carcinoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
- 8
- Study locations
Study Summary
The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC) and translocation-associated renal cell cancer (tRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.
Primary Outcome
The phase 1b portion of the trial will require between 4 and 24 patients in a 3+3 dose escalation design across four planned separate dose levels. The MTD will be defined as the dose level at which a dose limiting toxicity (DLT) occurs in at most 1 out of 6 patients in that dose level. CTCAE v5.0 will be used for toxicity evaluation.
Conditions Studied
Interventions
- DRUG Abemaciclib
- DRUG Cabozantinib
Study Locations (8)
New York
- Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering West Harrison (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Maryland
- Johns Hopkins University (Data Collection Only) - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
What NCT06835972 shows while recruiting
NCT06835972 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 142-participant average among 37 other Metastatic Renal Cell Carcinoma trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Metastatic Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Abemaciclib is the first listed.
NCT06835972 lists 8 locations in 3 states (New York, New Jersey, Maryland).
Frequently Asked Questions
What is clinical trial NCT06835972 about?
NCT06835972 is a clinical study titled "A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)". The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC) and translocation-associated renal cell cancer (tRCC). The researchers will test different dos...
What is the current status of trial NCT06835972?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2025-02-14. Estimated completion is 2027-02.
What conditions does trial NCT06835972 study?
This clinical trial studies the following conditions: Metastatic Renal Cell Carcinoma, Translocation Renal Cell Carcinoma.
What interventions are being tested in trial NCT06835972?
The interventions under investigation include: Abemaciclib (DRUG), Cabozantinib (DRUG).
Who is sponsoring clinical trial NCT06835972?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06835972 being conducted?
This trial has 8 study locations across Maryland, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06835972's enrollment target sits among peer trials
43 22nd of 37 higher than 16 of 37 other Metastatic Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
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