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NCT03572634 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03572634: Clinical Trial Phase 1 study, sponsored by Sumitomo Pharma America.
NCT03572634 is a Phase 1 study that was terminated before completion, run by Sumitomo Pharma America. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03572634, a Phase 1 study, was terminated before completion, sponsored by Sumitomo Pharma America.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
TP-0903 is an inhibitor of AXL kinase. TP-0903 has shown potent inhibition of AXL kinase and other TAM family members in a biochemical kinase assay. TP-0903 demonstrates corresponding activity in cancer cell lines and mouse xenograft efficacy models. TP-0903 is shown to block cancer cell epithelial-to-mesenchymal transitions. AXL was identified as a potential therapeutic target in chronic lymphocytic leukemia (CLL). TP 0903 was shown to induce apoptosis in CLL B-cells taken directly from patients.TP-0903 was equally potent against CLL cells regardless of risk-factor. TP-0903 is a novel oral inhibitor that targets AXL kinase and reverses the mesenchymal phenotype associated with advanced cancers. TP-0903 has demonstrated profound single agent activity in CLL B cells taken directly from patients even if the patient has high risk factors (ie, 17p/P53 deletions) or progressed on other agents (ie, ibrutinib). TP-0903 is currently being evaluated in patients with refractory solid tumors (TP-0903-101). This proposed study is designed to identify the maximum tolerated dose (MTD), safety profile and recommended Phase 2 dose (RP2D) of TP-0903 in patients with previously treated CLL. Treatment cycles may be repeated if the patient continues to show benefit and if TP-0903 is reasonably well tolerated. The study will investigate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of TP-0903.
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-0903
- COMBINATION_PRODUCT TP-0903 and ibrutinib combination therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2020-01-21 |
| Phase | Phase 1 |
Why NCT03572634 stopped before completion
NCT03572634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which TP-0903 is the first listed.
NCT03572634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03572634 about?
NCT03572634 is a clinical study titled "Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL". TP-0903 is an inhibitor of AXL kinase. TP-0903 has shown potent inhibition of AXL kinase and other TAM family members in a biochemical kinase assay. TP-0903 demonstrates corresponding activity in cancer cell lines and mouse xenograft efficacy models. TP-0903 is shown to block cancer cell epithelial-...
What is the current status of trial NCT03572634?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-06-10. Estimated completion is 2020-01-21.
What interventions are being tested in trial NCT03572634?
The interventions under investigation include: TP-0903 (DRUG), TP-0903 and ibrutinib combination therapy (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03572634?
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 NCT03572634's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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