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NCT04595747 · ClinicalTrials.gov registry record · Phase 2

Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)

A Phase 2 study of Metastatic Sarcoma and Locally Advanced Sarcoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
48
Enrollment target
18
Study locations

NCT04595747: Active Phase 2 study of Metastatic Sarcoma and Locally Advanced Sarcoma, sponsored by National Cancer Institute (NCI).

NCT04595747 is a Phase 2 study of Metastatic Sarcoma and Locally Advanced Sarcoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, above the 38-participant average among 12 other Metastatic Sarcoma trials with a reported enrollment target (26% higher). The trial reports 18 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04595747, a Phase 2 study of Metastatic Sarcoma and Locally Advanced Sarcoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
48 participants
Enrollment target
18
Study locations

Study Summary

This phase II trial studies the effect of rogaratinib in treating patients with sarcoma with a change in a group of proteins called fibroblast growth factor receptors (FGFRs) or SDH-deficient gastrointestinal stromal tumor (GIST). Rogaratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

The duration of overall response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

Conditions Studied

Metastatic Sarcoma Locally Advanced Sarcoma Locally Advanced Gastrointestinal Stromal Tumor Metastatic Gastrointestinal Stromal Tumor Stage III Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8 Stage III Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8 Stage IV Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8 Stage IV Small Intestinal, Esophageal, Colorectal, Mesenteric, and Peritoneal Gastrointestinal Stromal Tumor AJCC v8

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Positron Emission Tomography
  • PROCEDURE Biopsy Procedure

Study Locations (18)

Missouri

  • Siteman Cancer Center at West County Hospital - Creve Coeur
  • Washington University School of Medicine - St Louis
  • Siteman Cancer Center-South County - St Louis

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • City of Hope at Irvine Lennar - Irvine

Florida

  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation - Plantation

Maryland

  • National Cancer Institute Developmental Therapeutics Clinic - Bethesda
  • National Institutes of Health Clinical Center - Bethesda

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Illinois

  • Northwestern University - Chicago

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Michigan

  • University of Michigan Rogel Cancer Center - Ann Arbor

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2021-05-03
Est. Completion 2026-07-01
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT04595747 still lists

NCT04595747 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, above the 38-participant average among 12 other Metastatic Sarcoma trials with a reported enrollment target (26% higher).

The record links to 8 conditions, with Metastatic Sarcoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04595747 lists 18 locations in 13 states (Missouri, California, Florida).

Frequently Asked Questions

What is clinical trial NCT04595747 about?

NCT04595747 is a clinical study titled "Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST)". This phase II trial studies the effect of rogaratinib in treating patients with sarcoma with a change in a group of proteins called fibroblast growth factor receptors (FGFRs) or SDH-deficient gastrointestinal stromal tumor (GIST). Rogaratinib may stop the growth of tumor cells by blocking some of th...

What is the current status of trial NCT04595747?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2021-05-03. Estimated completion is 2026-07-01.

What conditions does trial NCT04595747 study?

This clinical trial studies the following conditions: Metastatic Sarcoma, Locally Advanced Sarcoma, Locally Advanced Gastrointestinal Stromal Tumor, Metastatic Gastrointestinal Stromal Tumor, Stage III Gastric and Omental Gastrointestinal Stromal Tumor AJCC v8.

What interventions are being tested in trial NCT04595747?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE).

Who is sponsoring clinical trial NCT04595747?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04595747 being conducted?

This trial has 18 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Sarcoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04595747's enrollment target sits among peer trials

48 4th of 12 higher than 9 of 12 other Metastatic Sarcoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Sarcoma 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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Related registry views

Source: ClinicalTrials.gov NCT04595747, the US trial registry maintained by the National Library of Medicine. NCT04595747 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.