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NCT02407080 · ClinicalTrials.gov registry record · Phase 1
Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia
A Phase 1 study, sponsored by John Mascarenhas.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT02407080 is a Phase 1 study that has completed, run by John Mascarenhas. The registered enrollment target is 13 participants.
The verdict
NCT02407080, a Phase 1 study, has completed, sponsored by John Mascarenhas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increase the risk of developing blood clots. The purpose of Part A of this study is to test the safety and tolerability of drug RG7388 patients and identify the recommended phase II dose in a single agent dose escalation study. The investigators want to find out what effects, good and/or bad it has on the disease. The purpose of Part B of this study is to test the safety and tolerability of the combination of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from Part A who did not achieve at least a partial response by the end of three cycles of single agent RG7388. Essential Thrombocythemia (ET) and Polycythemia Vera (PV) have been difficult diseases to treat. RG7388 is a selective inhibitor of the p53-MDM2 binding that frees p53 from negative control and activates the p53 pathway in cancer cells, leading to cell cycle arrest and apoptosis in vitro and in vivo. It has been used to treat solid tumors and Acute Myelogenous Leukemia (AML) in clinical trials. Pegasys is a drug that is the standard of care for patients who have Chronic Hepatitis B (CHB). RG7388 is a drug that is not yet approved by the Federal Drug Administration (FDA) for the treatment of patients with essential thrombocythemia or polycythemia vera. Pegasys is a drug that is approved by the FDA for the treatment of CHB. The use of RG7388 alone and in combination with Pegasys is experimen
Interventions
- DRUG Pegasys
- DRUG RG7388
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2015-04 |
| Est. Completion | 2018-12-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02407080
The ClinicalTrials.gov registry entry for NCT02407080 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is John Mascarenhas, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Pegasys is the first listed.
NCT02407080 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02407080 about?
NCT02407080 is a clinical study titled "Open Label Study of Single Agent Oral RG7388 in Patients With Polycythemia Vera and Essential Thrombocythemia". This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normall...
What is the current status of trial NCT02407080?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2015-04. Estimated completion is 2018-12-19.
What interventions are being tested in trial NCT02407080?
The interventions under investigation include: Pegasys (DRUG), RG7388 (DRUG).
Who is sponsoring clinical trial NCT02407080?
This trial is sponsored by John Mascarenhas, which has 11 total clinical trials registered on ClinicalTrials.gov.
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