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NCT01752920 · ClinicalTrials.gov registry record · Phase 1

Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations

A Phase 1 study of Solid Tumor, sponsored by Basilea Pharmaceutica.

Completed
Registry status
Phase 1
Development phase
119
Enrollment target
12
Study locations

NCT01752920 is a Phase 1 study of Solid Tumor that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 119 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (46% lower). The trial reports 12 study locations across 9 states.

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The verdict

NCT01752920, a Phase 1 study of Solid Tumor, has completed, sponsored by Basilea Pharmaceutica.

COMPLETED
Registry status
Phase 1
Development phase
119 participants
Enrollment target
12
Study locations

Study Summary

This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Expanded Cohort, signal finding).

Conditions Studied

Solid Tumor

Interventions

  • DRUG Derazantinib low dose range
  • DRUG Derazantinib middle dose range
  • DRUG Derazantinib high dose range
  • DRUG Derazantinib at recommended phase 2 dose (RP2D)

Study Locations (12)

Other

  • Istituto Clinico Humanitas - Milan
  • Istituto Nazionale Tumori (National Cancer Institute) - Milan
  • Instituto Oncologico Veneto, IRCCS - Padua
  • Azienda Ospedaliero-Universitaria Pisana - U.O. Oncologia Medica 2 Univ. - Pisa

Arizona

  • Scottsdale Healthcare Research Institute - Scottsdale

Georgia

  • Emory University, Winship Cancer Institute - Atlanta

Michigan

  • Karmanos Cancer Institute, Detroit - Detroit

Nevada

  • Comprehensive Cancer Centers of Nevada - Las Vegas

New York

  • Montefiore-Einstein Center for Cancer Care - The Bronx

Pennsylvania

  • University of Pennsylvania Hospital - Philadelphia

Texas

  • START - South Texas Accelerated Research Therapeutics, LLC - San Antonio

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2012-12-10
Est. Completion 2018-08-28
Phase Phase 1

Sponsor

Basilea Pharmaceutica

21 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01752920

The ClinicalTrials.gov registry entry for NCT01752920 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (46% lower). The listed sponsor is Basilea Pharmaceutica, which has 21 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Derazantinib low dose range is the first listed.

NCT01752920 reports 12 study locations spanning 9 distinct geographic areas - top geographies include Other, Arizona, Georgia.

Frequently Asked Questions

What is clinical trial NCT01752920 about?

NCT01752920 is a clinical study titled "Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations". This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR genetic aberrations, including iCCA with FGFR2 gene fusion (Part 2; Ex...

What is the current status of trial NCT01752920?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 119 participants. The study started on 2012-12-10. Estimated completion is 2018-08-28.

What conditions does trial NCT01752920 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT01752920?

The interventions under investigation include: Derazantinib low dose range (DRUG), Derazantinib middle dose range (DRUG), Derazantinib high dose range (DRUG), Derazantinib at recommended phase 2 dose (RP2D) (DRUG).

Who is sponsoring clinical trial NCT01752920?

This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01752920 being conducted?

This trial has 12 study locations across Arizona, Georgia, Michigan, Nevada, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.