Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05221320 · ClinicalTrials.gov registry record · Phase 2
Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies
A Phase 2 study, sponsored by BioMed Valley Discoveries.
- Terminated
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT05221320: Clinical Trial Phase 2 study, sponsored by BioMed Valley Discoveries.
NCT05221320 is a Phase 2 study that was terminated before completion, run by BioMed Valley Discoveries. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05221320, a Phase 2 study, was terminated before completion, sponsored by BioMed Valley Discoveries.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients enrolled must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages. The opening of stage two will be dependent on the observed responses in the patients enrolled in the first stage.
Primary Outcome
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Interventions
- DRUG Ulixertinib
- DRUG Hydroxychloroquine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2022-05-26 |
| Est. Completion | 2024-07-14 |
| Phase | Phase 2 |
Why NCT05221320 stopped before completion
NCT05221320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Ulixertinib is the first listed.
NCT05221320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05221320 about?
NCT05221320 is a clinical study titled "Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies". This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients enrolled must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed e...
What is the current status of trial NCT05221320?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2022-05-26. Estimated completion is 2024-07-14.
What interventions are being tested in trial NCT05221320?
The interventions under investigation include: Ulixertinib (DRUG), Hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT05221320?
This trial is sponsored by BioMed Valley Discoveries, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05221320's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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
- NCT03313011 · 47 participants
The Neurobiology of Two Distinct Types of Progressive Apraxia of Speech
- NCT03467516 · 47 participants · Phase 2
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
- NCT03886662 · 47 participants · Phase 1
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
- NCT04013802 · 47 participants · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI