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NCT02549937 · ClinicalTrials.gov registry record · Phase 1
A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors
A Phase 1 study of Tumors, sponsored by Hutchmed.
- Completed
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
- 12
- Study locations
NCT02549937: Completed Phase 1 study of Tumors, sponsored by Hutchmed.
NCT02549937 is a Phase 1 study of Tumors that has completed, run by Hutchmed. The registered enrollment target is 130 participants, below the 193-participant average among 20 other Tumors trials with a reported enrollment target (33% lower). The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02549937, a Phase 1 study of Tumors, has completed, sponsored by Hutchmed.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
- 12
- Study locations
Study Summary
Primary Objective Dose Escalation: To evaluate the safety and tolerability of surufatinib in patients with advanced solid tumors and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D). Primary Objective Dose Expansion: To evaluate the anticancer activity of surufatinib in patients with advanced Biliary Tract Cancer (BTC), patients with advanced pancreatic neuroendocrine tumors (pNETs), patients with locally advanced, unresectable, metastatic extra-pancreatic neuroendocrine tumors (EP-NETs), and patients with soft tissue sarcomas (STS) treated at a dose of 300 mg QD. Secondary Objective: To evaluate the pharmacokinetic profile of multiple dose surufatinib in patients with advanced solid tumors and to evaluate the anti cancer activity of surufatinib in patients with advanced solid tumors.
Primary Outcome
A DLT was defined as any of the following toxicities determined by the Investigator to have a reasonable possibility of being related to surufatinib. Adverse events (AE) were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Any Grade 4 non-hematological toxicity; any Grade 3 non-hematological toxicity except for nausea/vomiting, diarrhea, constipation, electrolyte imbalances, or transient hypertension downgraded within 3 days with
Conditions Studied
Interventions
- DRUG surufatinib
Study Locations (12)
Texas
- Mary Crowley Cancer Research Center - Dallas
- Baylor Charles A. Sammons Cancer Center - Dallas
- MD Anderson Cancer Center - Houston
Colorado
- Rocky Mountain Cancer Center - Denver
- SCRI at HealthONE - Denver
New York
- Mount Sinai Hospital - New York
- Memorial Sloan Kettering Cancer Center - New York
California
- City of Hope Comprehensive Cancer Center - Los Angeles
Florida
- Florida Cancer Specialists - Sarasota
Tennessee
- Tennessee Oncology - Nashville
Virginia
- Virginia Cancer Specialists, PC - Fairfax
Other
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2015-11 |
| Est. Completion | 2023-06-02 |
| Phase | Phase 1 |
What the finished NCT02549937 record still lists
NCT02549937 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 193-participant average among 20 other Tumors trials with a reported enrollment target (33% lower).
The record links to 1 condition, with Tumors appearing as the primary indexed condition, and to 1 intervention - of which surufatinib is the first listed.
NCT02549937 lists 12 locations in 8 states (Texas, Colorado, New York).
Frequently Asked Questions
What is clinical trial NCT02549937 about?
NCT02549937 is a clinical study titled "A Multi-Center, Open-Label Study of Surufatinib (HMPL-012) in Patients With Advanced Solid Tumors". Primary Objective Dose Escalation: To evaluate the safety and tolerability of surufatinib in patients with advanced solid tumors and to determine the maximum tolerable dose (MTD) or recommended phase II dose (RP2D). Primary Objective Dose Expansion: To evaluate the anticancer activity of surufati...
What is the current status of trial NCT02549937?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2015-11. Estimated completion is 2023-06-02.
What conditions does trial NCT02549937 study?
This clinical trial studies the following conditions: Tumors.
What interventions are being tested in trial NCT02549937?
The interventions under investigation include: surufatinib (DRUG).
Who is sponsoring clinical trial NCT02549937?
This trial is sponsored by Hutchmed, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02549937 being conducted?
This trial has 12 study locations across California, Colorado, Florida, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02549937's enrollment target sits among peer trials
130 7th of 20 higher than 14 of 20 other Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tumors 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.
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