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NCT03251378 · ClinicalTrials.gov registry record · Phase 1
A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers
A Phase 1 study, sponsored by Hutchison Medipharma Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 129
- Enrollment target
NCT03251378: Completed Phase 1 study, sponsored by Hutchison Medipharma Limited.
NCT03251378 is a Phase 1 study that has completed, run by Hutchison Medipharma Limited. The registered enrollment target is 129 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03251378, a Phase 1 study, has completed, sponsored by Hutchison Medipharma Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 129 participants
- Enrollment target
Study Summary
An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
Primary Outcome
Dose-limiting toxicity was defined as: Any Grade 4 non-hematologic toxicity; Any Grade 3 non-hematologic toxicity related to study drug except for nausea/vomiting, diarrhea, constipation, hypertension, and electrolyte imbalances downgraded within 3-days with appropriate supportive treatment; Grade 4 neutropenia lasting \>3 days; Grade 3 febrile neutropenia (absolute neutrophil count \[ANC\] \<1.0\*10\^9 per liter \[/L\] with a single temperature of greater than (\>) 38.3 degree centigrade (°C) o
Interventions
- DRUG Fruquintinib (HMPL-013)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2017-12-11 |
| Est. Completion | 2023-03-30 |
| Phase | Phase 1 |
What the finished NCT03251378 record still lists
NCT03251378 is an interventional study that assigns participants to a tested intervention. The registered 129 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (115% higher).
The record links to 0 conditions, and to 1 intervention - of which Fruquintinib (HMPL-013) is the first listed.
NCT03251378 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03251378 about?
NCT03251378 is a clinical study titled "A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers". An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.
What is the current status of trial NCT03251378?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 129 participants. The study started on 2017-12-11. Estimated completion is 2023-03-30.
What interventions are being tested in trial NCT03251378?
The interventions under investigation include: Fruquintinib (HMPL-013) (DRUG).
Who is sponsoring clinical trial NCT03251378?
This trial is sponsored by Hutchison Medipharma Limited, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03251378's enrollment target sits among peer trials
129 451st of 2000 higher than 1,549 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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