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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 is a Phase 1 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 74 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03604783
The ClinicalTrials.gov registry entry for NCT03604783 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TP-1287 is the first listed.
NCT03604783 reports 0 study locations.
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.
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