Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02164240 · ClinicalTrials.gov registry record · Phase 1
Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST
A Phase 1 study of Gastrointestinal Stromal Tumor, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02164240: Completed Phase 1 study of Gastrointestinal Stromal Tumor, sponsored by Dana-Farber Cancer Institute.
NCT02164240 is a Phase 1 study of Gastrointestinal Stromal Tumor that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 14 participants, below the 68-participant average among 8 other Gastrointestinal Stromal Tumor trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02164240, a Phase 1 study of Gastrointestinal Stromal Tumor, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to determine the safety and tolerability of sunitinib alternating with regorafenib in participants with advanced gastrointestinal stromal tumor GIST, if the standard approved therapies (imatinib, sunitinib and regorafenib) have failed to control the disease. Additionally, this study seeks to determine the highest dose that can be given safely for this combination of drugs.
Primary Outcome
Dose-escalation cohort is to determine the frequency and characteristics of DLTs of alternation of sunitinib and regorafenib at each dose level during the first cycle of therapy. Toxicity will be graded accordingly with NCI CTCAE version 4.0
Conditions Studied
Interventions
- DRUG Sunitinib
- DRUG Regorafenib
Study Locations (1)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-07 |
| Est. Completion | 2021-05 |
| Phase | Phase 1 |
What the finished NCT02164240 record still lists
NCT02164240 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 68-participant average among 8 other Gastrointestinal Stromal Tumor trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Gastrointestinal Stromal Tumor appearing as the primary indexed condition, and to 2 interventions - of which Sunitinib is the first listed.
NCT02164240 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02164240 about?
NCT02164240 is a clinical study titled "Phase Ib Study of SUnitinib Alternating With REgorafenib in Patients With Metastatic and/or Unresectable GIST". The purpose of this research study is to determine the safety and tolerability of sunitinib alternating with regorafenib in participants with advanced gastrointestinal stromal tumor GIST, if the standard approved therapies (imatinib, sunitinib and regorafenib) have failed to control the disease. Add...
What is the current status of trial NCT02164240?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-07. Estimated completion is 2021-05.
What conditions does trial NCT02164240 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumor.
What interventions are being tested in trial NCT02164240?
The interventions under investigation include: Sunitinib (DRUG), Regorafenib (DRUG).
Who is sponsoring clinical trial NCT02164240?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02164240 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gastrointestinal Stromal 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 NCT02164240's enrollment target sits among peer trials
14 9th of 8 the lowest of 8 other Gastrointestinal Stromal Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastrointestinal Stromal 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
-
Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer
COMPLETED · Phase 1
-
Sorafenib in Treating Patients With Malignant Gastrointestinal Stromal Tumor That Progressed During or After Previous Treatment With Imatinib Mesylate and Sunitinib Malate
ACTIVE NOT RECRUITING · Phase 2
-
Nivolumab With or Without Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumor That Is Metastatic or Cannot Be Removed by Surgery
COMPLETED · Phase 2
-
Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
COMPLETED · Phase 2
-
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer
COMPLETED · Phase 2
-
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
COMPLETED · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05065671 · 14 participants · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia