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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: Completed Phase 1 study of Solid Tumor, sponsored by Basilea Pharmaceutica.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2012-12-10 |
| Est. Completion | 2018-08-28 |
| Phase | Phase 1 |
What the finished NCT01752920 record still lists
NCT01752920 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (46% lower).
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 lists 12 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Solid Tumor
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 NCT01752920's enrollment target sits among peer trials
119 76th of 196 higher than 121 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor 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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A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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