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NCT03604783 · ClinicalTrials.gov registry record · Phase 1
Phase 1, First-in-human Study of Oral TP-1287 in Patients with Advanced Solid Tumors
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT03604783: Clinical Trial Phase 1 study, sponsored by Sumitomo Pharma America.
NCT03604783 is a Phase 1 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03604783, a Phase 1 study, was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
TP-1287 is an oral phosphate prodrug of the CDK9 inhibitor, alvocidib. This is a Phase 1, open-label, dose-escalation, dose-expansion, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
Primary Outcome
A DLT is defined as a drug-related toxicity that is observed to occur within the first 28 days of treatment
Interventions
- DRUG TP-1287
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2018-12-26 |
| Est. Completion | 2024-01-10 |
| Phase | Phase 1 |
Why NCT03604783 stopped before completion
NCT03604783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 1 intervention - of which TP-1287 is the first listed.
NCT03604783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03604783 about?
NCT03604783 is a clinical study titled "Phase 1, First-in-human Study of Oral TP-1287 in Patients with Advanced Solid Tumors". TP-1287 is an oral phosphate prodrug of the CDK9 inhibitor, alvocidib. This is a Phase 1, open-label, dose-escalation, dose-expansion, safety, pharmacokinetics, and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-12...
What is the current status of trial NCT03604783?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2018-12-26. Estimated completion is 2024-01-10.
What interventions are being tested in trial NCT03604783?
The interventions under investigation include: TP-1287 (DRUG).
Who is sponsoring clinical trial NCT03604783?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03604783's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 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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