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NCT04150042 · ClinicalTrials.gov registry record · Phase 1
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
A Phase 1 study of Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by General Oncology.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT04150042: Recruiting Phase 1 study of Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, sponsored by General Oncology.
NCT04150042 is a Phase 1 study of Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by General Oncology. The registered enrollment target is 24 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04150042, a Phase 1 study of Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by General Oncology.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.
Primary Outcome
Sinusoidal obstruction syndrome diagnosis and grading will use the European Society for Blood and Marrow Transplantation's Revised Diagnosis and Severity Criteria for Sinusoidal Obstruction Syndrome/Veno-Occlusive Disease in Adult Patients as published in 2016. Gradings are from mild to very severe (multi-organ dysfunction/multi-organ failure).
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Vitamin C
- DRUG BCNU
- DRUG Vitamin B12B
- DEVICE Autologous Hematopoietic Stem Cells
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-01-13 |
| Est. Completion | 2028-12 |
| Phase | Phase 1 |
What NCT04150042 shows while recruiting
NCT04150042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (94% lower).
The record links to 10 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 5 interventions - of which Melphalan is the first listed.
NCT04150042 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04150042 about?
NCT04150042 is a clinical study titled "SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells". The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitami...
What is the current status of trial NCT04150042?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-01-13. Estimated completion is 2028-12.
What conditions does trial NCT04150042 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Metastatic Pancreatic Ductal Adenocarcinoma, Breast Cancer Metastatic.
What interventions are being tested in trial NCT04150042?
The interventions under investigation include: Melphalan (DRUG), Vitamin C (DRUG), BCNU (DRUG), Vitamin B12B (DRUG), Autologous Hematopoietic Stem Cells (DEVICE).
Who is sponsoring clinical trial NCT04150042?
This trial is sponsored by General Oncology, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04150042 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04150042's enrollment target sits among peer trials
24 216th of 278 higher than 60 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer 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.
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