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NCT04308330 · ClinicalTrials.gov registry record · Phase 1
Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
A Phase 1 study, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04308330: Recruiting Phase 1 study, sponsored by New York Medical College.
NCT04308330 is a Phase 1 study that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04308330, a Phase 1 study, is actively recruiting participants, sponsored by New York Medical College.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this study are: * To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects; * To learn what kind of side effects this four drug combination can cause; * To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells; * To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.
Primary Outcome
A minimum of 3 evaluable patients will be entered at each dose level. If no significant dose limiting toxicity is discovered, a maximum of 3 dose levels will be evaluated. The minimum patient enrollment will be 3 patients. Many of the patients enrolled on this trial are expected to be heavily pretreated. All patients will be given a VIT only "window" to evaluate adequate bone marrow reserve to tolerate protocol therapy. We expect that at most 20% of patients will not be able to tolerate VIT or V
Interventions
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-03-17 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04308330 shows while recruiting
NCT04308330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Vorinostat is the first listed.
NCT04308330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04308330 about?
NCT04308330 is a clinical study titled "Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies". Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this stu...
What is the current status of trial NCT04308330?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-03-17. Estimated completion is 2027-12-31.
What interventions are being tested in trial NCT04308330?
The interventions under investigation include: Vorinostat (DRUG).
Who is sponsoring clinical trial NCT04308330?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04308330's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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