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NCT05093322 · ClinicalTrials.gov registry record · Phase 1
A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors
A Phase 1 study, sponsored by Hutchmed.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT05093322: Completed Phase 1 study, sponsored by Hutchmed.
NCT05093322 is a Phase 1 study that has completed, run by Hutchmed. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05093322, a Phase 1 study, has completed, sponsored by Hutchmed.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory solid tumors or lymphoma. The study will be conducted in 2 parts.
Primary Outcome
A DLT was defined as any of following events that were attributable to study treatment (at least possibly related). Adverse events (AE) were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. * Any Grade 3 or greater nonhematological toxicity. * Grade 3 liver enzyme elevation. * Cases of Hy's law. * Any Grade 2 nonhematological toxicity that persisted for \>= 7 days. * Any Grade 4 hypertension. * Grade 3 corrected QT interval prolong
Interventions
- DRUG Surufatinib in combination with Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2023-04-25 |
| Phase | Phase 1 |
What the finished NCT05093322 record still lists
NCT05093322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 1 intervention - of which Surufatinib in combination with Gemcitabine is the first listed.
NCT05093322 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05093322 about?
NCT05093322 is a clinical study titled "A Study of Surufatinib in Combination With Gemcitabine in Pediatric, Adolescent, and Young Adult Patients With Recurrent or Refractory Solid Tumors". The purpose of this study is to evaluate the safety and tolerability of surufatinib, thereby identifying the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of surufatinib administered in combination with gemcitabine in pediatric patients with recurrent or refractory solid tumors...
What is the current status of trial NCT05093322?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-11-30. Estimated completion is 2023-04-25.
What interventions are being tested in trial NCT05093322?
The interventions under investigation include: Surufatinib in combination with Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT05093322?
This trial is sponsored by Hutchmed, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05093322's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 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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