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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 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.

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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.

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

FieldValue
Enrollment Target 130 participants
Start Date 2015-11
Est. Completion 2023-06-02
Phase Phase 1

Sponsor

Hutchmed

17 total trials

What the Registry Record Tells You About NCT02549937

The ClinicalTrials.gov registry entry for NCT02549937 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 20 other Tumors trials with a reported enrollment target (33% lower). The listed sponsor is Hutchmed, which has 17 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.